ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2023-00301
- Event Type
- Malfunction
- Date Received
- December 22, 2023
- Date of Event
- December 13, 2023
- Report Date
- January 24, 2024
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002474489
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A REPAIR OF A CHRONIC DISSECTION WITH AN EXISTING NON-COOK PROXIMAL STENT GRAFT IN WHICH A ZDEG-P-32-142-PF-US (COMPLAINT DEVICE) WAS USED. THERE WAS NO NOTABLE TORTUOSITY OR ANGULATION. THE DEVICE DEPLOYED FINE AND AS INTENDED, HOWEVER THE SAFETY WIRE RELEASE WAS EXTREMELY DIFFICULT TO RELEASE. THE SAME DEVICE WAS PLACED DISTALLY WITH NO ISSUES ON RELEASE OR DEPLOYMENT. REVIEW OF THE DEVICE HISTORY RECORD FOUND THAT ALL DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE RELEASE AND NO INDICATION THAT THE DEVICE WAS PRODUCED OUTSIDE OF SPECIFICATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR THE INVESTIGATION AND NO IMAGING WAS PROVIDED. BASED ON THE RECEIVED INFORMATION IT HAS NOT BEEN POSSIBLE TO DETERMINE THE CAUSE OF DIFFICULT RELEASE OF THE GREEN TRIGGER-WIRE RELEASE MECHANISM. RELEVANT PERSONNEL HAVE BEEN INFORMED OF THIS COMPLAINT AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. IT IS NOTED THAT THE ZDEG WAS USED IN COMBINATION WITH A NON-COOK DEVICE, WHICH IS OUTSIDE OF INTENDED USE FOR THIS TYPE OF DEVICE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A REPAIR OF A CHRONIC DISSECTION WITH EXISTING PROXIMAL STENT GRAFT IN WHICH THE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT, G47448, WAS USED. THE GRAFT WAS BEING DEPLOYED INSIDE AN EXISTING SURGICAL GRAFT FROM ANOTHER MANUFACTURER. THERE WAS NO NOTABLE TORTUOSITY OR ANGULATION. THE DEVICE DEPLOYED FINE AND AS INTENDED, HOWEVER THE SAFETY WIRE RELEASE WAS EXTREMELY DIFFICULT TO RELEASE. ANOTHER UNIT OF THE SAME, G47448- LOT E4468992, WAS PLACED DISTALLY WITH NO ISSUES ON RELEASE OR DEPLOYMENT. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2264960 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E4369124 | 10827002474489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |