Device product
Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Z-1976-2021
Product summary
- Event
- Event 88028
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 devices
- Official record key
device-enforcement:Z-1976-2021
Official wording
Reason: Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Code information: Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787; V30064789; V30064790;
Distribution pattern: U.S. Nationwide distribution in the state of GA. O.U.S.: None
Derived failure modes
-
Unknown
Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.