ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT
Report
- Report Number
- 3002808486-2022-00923
- Event Type
- Malfunction
- Date Received
- August 17, 2022
- Date of Event
- August 15, 2022
- Report Date
- September 28, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002474854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K): P180001 INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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.
MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: THE GREEN TRIGGER-WIRE MECHANISM WOULD NOT DETACH AND THE WIRES WERE PULLED WITH HEMOSTATS ONE AT A TIME. THE STENT WAS SUCCESSFULLY PLACED WITHOUT REPORTED HARM TO THE PATIENT. THE ZDEG DEVICE WITHOUT PROTECTION TUBE, SHIPPING STYLET, STENT GRAFT, AND PEEL-AWAY WAS RETURNED. THE GREEN RELEASE KNOB WAS PULLED 11MM DOWN THE HANDLE MAIN BODY AND ROTATED APPROX. 90° COUNTERCLOCKWISE. GROOVES NOTED IN THE HANDLE MAIN BODY CONFIRMED THE 90° ROTATION AND INDICATED THAT THE GREEN RELEASE KNOB HAD BEEN ROTATED DURING RETRACTION. THE EXACT REASON WHY THE TRIGGER-WIRE KNOB COULD NOT BE PULLED CANNOT BE DETERMINED, BUT IF ROTATED, THE WIRES MAY GET CAUGHT BETWEEN THE HANDLE AND THE KNOB AND CONSEQUENTLY THE RELEASE KNOB MAY STICK. REFERENCE IS MADE TO THE INSTRUCTIONS FOR USE SPECIFYING NOT TO ROTATE THE GREEN TRIGGER WIRE KNOB DURING WITHDRAWAL, BUT APPROPRIATE ACTIONS HAVE BEEN INITIATED, TOO, TO ADDRESS THE DIFFICULTIES IN WITHDRAWING THE GREEN TRIGGER WIRE MECHANISM. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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: THE TRIGGER WIRE RELEASE MECHANISM DID NOT DETACH FROM THE INTRODUCTION SYSTEM. THE GREEN TRIGGER WAS MUSCLED BACK AND PULL THE WIRES WITH HEMOSTATS - ONE AT A TIME. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2012347 | ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G47485 | E4250970 | 10827002474854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male |