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Zenith Alpha Thoracic Endovascular Grafts (2017-06-23)

Report a Concern
Starting date:
June 23, 2017
Posting date:
June 30, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-63788

Affected Products

  1. Zenith Alpha Thoracic Endovascular Graft - Proximal Component
  2. Zenith Alpha Thoracic Endovascular Graft - Proximal Tapered Component
  3. Zenith Alpha Thoracic Endovascular Graft - Distal Component

Reason

William Cook Europe ApS has learned of an issue affecting the Zenith Alpha Thoracic Endovascular Grafts.  As described in the recent field safety notice 2017FA0001 of March 2017 regarding the Zenith Alpha Thoracic Endovascular Graft, there were complaints involving thrombosis/occlusion of the product when used to treat blunt thoracic aortic injury (BTAI). Since that time, Cook Medical has received additional complaints for the same problem. Although the complaints were from patients treated prior to issuance of the above noted field safety notice, cook medical is initiating a voluntary correction of the instructions for use (IFU) and is also voluntarily removing specific sizes of the Zenith Alpha Thoracic Endovascular Graft from the market. The manufacturer is voluntarily removing the indication for blunt thoracic aortic injury. The specific sizes of 18-22 mm used for the BTAI indication is being recalled from the market and will no longer be available.  The IFU will be corrected for the remaining sizes on the market used for endovascular treatment of patients with isolated lesions of the descending thoracic aorta.

Affected products

  1. Zenith Alpha Thoracic Endovascular Graft - Proximal

Lot or serial number

All lots

Model or catalog number
  • ZTA-P-18-105
  • ZTA-P-18-127
  • ZTA-P-20-105
  • ZTA-P-20-127
  • ZTA-P-22-105
  • ZTA-P-24-105
  • ZTA-P-26-105
  • ZTA-P-26-149
  • ZTA-P-28-109
  • ZTA-P-28-155
  • ZTA-P-28-201
  • ZTA-P-30-109
  • ZTA-P-30-132
  • ZTA-P-30-155
  • ZTA-P-30-201
  • ZTA-P-32-109
  • ZTA-P-32-155
  • ZTA-P-32-201
  • ZTA-P-34-113
  • ZTA-P-34-161
  • ZTA-P-34-209
  • ZTA-P-36-113
  • ZTA-P-36-161
  • ZTA-P-36-209
  • ZTA-P-38-117
  • ZTA-P-38-142
  • ZTA-P-38-167
  • ZTA-P-38-217
  • ZTA-P-40-117
  • ZTA-P-40-167
  • ZTA-P-40-217
  • ZTA-P-42-121
  • ZTA-P-42-173
  • ZTA-P-42-225
  • ZTA-P-44-125
  • ZTA-P-44-179
  • ZTA-P-44-233
  • ZTA-P-46-125
  • ZTA-P-46-152
  • ZTA-P-46-179
  • ZTA-P-46-233
Companies
Manufacturer
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK

B. Zenith Alpha Thoracic Endovascular Graft - Proximal Tapered Component

Lot or serial number

All lots

Model or catalog number

ZTA-PT-30-26-108
ZTA-PT-32-28-178
ZTA-PT-32-28-201
ZTA-PT-34-30-161
ZTA-PT-34-30-209
ZTA-PT-36-32-161
ZTA-PT-36-32-209
ZTA-PT-38-34-167
ZTA-PT-38-34-217
ZTA-PT-40-36-167
ZTA-PT-40-36-217
ZTA-PT-42-38-173
ZTA-PT-42-38-225
ZTA-PT-44-40-179
ZTA-PT-44-40-233
ZTA-PT-46-42-179
ZTA-PT-46-42-233

Companies
Manufacturer
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK

C. Zenith Alpha Thoracic Endovascular Graft - Distal Component

Lot or serial number

All lots

Model or catalog number

ZTA-D-30-160
ZTA-D-32-160
ZTA-D-34-190
ZTA-D-36-190
ZTA-D-38-197
ZTA-D-40-147
ZTA-D-40-197
ZTA-D-42-204
ZTA-D-44-211
ZTA-D-46-211
ZTA-DE-26-104
ZTA-DE-30-108
ZTA-DE-34-112
ZTA-DE-38-91
ZTA-DE-42-94

Companies
Manufacturer
William Cook Europe APS
Sandet 6
Bjaeverskov
4632
DENMARK