ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2016-00881
- Event Type
- Injury
- Date Received
- September 8, 2016
- Date of Event
- March 21, 2016
- Report Date
- June 29, 2017
- Manufacturer
- COOK INC
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). INVESTIGATION/EVALUATION NO PRODUCT WAS RETURNED; HOWEVER, DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, TRENDS, AND A VIEWING OF THE PROVIDED CD DISC WAS CONDUCTED. THE CD IMAGING WAS SENT FOR OUTSIDE PROFESSIONAL CLINICAL REVIEW. THE EVALUATION OF THE IMAGING PROVIDED THE FOLLOWING: ALTHOUGH THE PROVIDED IMAGING CANNOT CONFIRM THE REPORTED GRAFT TEARS, IT DOES SUPPORT OVER DILATION WITH A CODA BALLOON TEARING THE MAIN BODY AND LEFT LIMB AS THE MOST LIKELY SCENARIO. THE CODA BALLOON COMPLIANCE LEAVES THE FABRIC VULNERABLE WHERE IT IS LESS SUPPORTED. THE REPORTED LOCATIONS OF THE LEAKS MATCH THE LOCATIONS WHERE THE FABRIC WOULD BE MOST AT RISK IN LIEU OF THE AGGRESSIVE ANGIOPLASTY LIKELY NECESSARY TO EXPAND THE STENOTIC DISTAL AORTA. IN ADDITION, SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE OBSERVED AS THE DISTAL AORTA WAS STENOTIC AND SEVERELY CALCIFIED. HOWEVER, THERE WERE NO SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE NOR RELATIVE TO THE USE OF THE DEVICE. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS, AND THAT THE DEVICE MEETS THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, NO EVIDENCE WAS FOUND INDICATING THAT THE DEVICE WAS MANUFACTURED OUTSIDE OF COOK INC. SPECIFICATIONS. NO ADDITIONAL EVALUATION COULD BE PERFORMED ON THE COMPLAINT DEVICE SINCE IT WAS NOT RETURNED AND SINCE NO IMAGING AFTER GRAFT PLACEMENT WAS RETURNED, THUS ANY POSSIBLE INTRINSIC DEFECT COULD NOT BE RULED OUT. WE HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA) NO FURTHER ACTION IS REQUIRED.
ON INITIAL REPORT INDICATES TWO SEPARATE ISSUES: MFR # 1820334-2016-00279: FABRIC TEAR WAS NOTED AND BELIEVED TO BE BETWEEN THE SECOND AND THIRD STENT ON THE RIGHT SIDE; TYPE III ENDO LEAK: MFR # 1820334-2016-00881: A SECOND LIMB ZSLE-13-56-ZT WAS ADVANCED AND POSITIONED INSIDE OF THE LEFT LIMB IN ORDER TO SEAL OUT THE MOST DISTAL LEAK WHICH WAS PRESUMED TO BE FROM A STENT RUPTURE AND PRESUMED FABRIC TEAR INVESTIGATION/EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, TRENDS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. IMAGING REVIEW: CLINICAL ASSESSMENT ALTHOUGH THE PROVIDED IMAGING CANNOT CONFIRM THE REPORTED GRAFT TEARS, IT DOES SUPPORT OVER-DILATION WITH A CODA BALLOON TEARING THE MAINBODY AND LEFT LIMB AS THE MOST LIKELY SCENARIO. THE CODA BALLOON COMPLIANCE LEAVES THE FABRIC VULNERABLE WHERE IT IS LESS SUPPORTED. THE REPORTED LOCATIONS OF THE LEAKS MATCH THE LOCATIONS WHERE THE FABRIC WOULD BE MOST AT RISK IN LIEU OF THE AGGRESSIVE ANGIOPLASTY LIKELY NECESSARY TO EXPAND THE STENOTIC DISTAL AORTA. IN ADDITION, SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE OBSERVED AS THE DISTAL AORTA WAS STENOTIC AND SEVERELY CALCIFIED. HOWEVER, THERE WERE NO SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE NOR RELATIVE TO THE USE/DESIGN/PERFORMANCE OF THE DEVICE. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND CORRECT DEPLOYMENT PROCEDURE: POTENTIAL ADVERSE EVENTS: ENDOLEAK DIRECTIONS FOR USE: POSITION ANGIOGRAPHIC CATHETER JUST ABOVE THE LEVEL OF THE RENAL ARTERIES. PERFORM ANGIOGRAPHY TO VERIFY THAT THE RENAL ARTERIES ARE PATENT AND THAT THERE ARE NO ENDOLEAKS. VERIFY PATENCY OF INTERNAL ILIAC ARTERIES. CONFIRM THERE ARE NO ENDOLEAKS OR KINKS AND VERIFY POSITION OF PROXIMAL GOLD RADIOPAQUE MARKERS. REMOVE THE SHEATHS, WIRE AND CATHETERS. NOTE: IF ENDOLEAKS OR OTHER PROBLEMS ARE OBSERVED, REFER TO SECTION 10.2 ANCILLARY DEVICES. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND RESULTS OF THE INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.
IT WAS REPORTED THAT AN (B)(6) MALE WITH AN INFRARENAL ABDOMINAL AORTIC ANEURYSM; FOR WHICH HE WAS PRE-OPED AND CONSENTED, WAS DEEMED A CANDIDATE FOR AN ENDOVASCULAR ANEURYSM REPAIR. A RETROGRADE ILIAC ARTERY ANGIOGRAM WAS PERFORMED TO MARK THE ORIGIN OF THE RIGHT INTERNAL ILIAC ARTERY, AND VIA THE RIGHT GROIN, A RIGHT LIMB EXTENSION ZSLE WAS ADVANCED, POSITIONED AND DEPLOYED SUCCESSFULLY AND UNEVENTFULLY, WITH THE DISTAL LANDING ZONE JUST ABOVE THE ORIGIN OF THE RIGHT INTERNAL ILIAC ARTERY; WHICH WAS CONFIRMED BY ANGIOGRAPHY VIA OBLIQUE VIEWS TO PRESERVE INTERNAL ILIAC ARTERY FLOW. FOLLOWING THIS VIA BILATERAL GROINS, CODA BALLOONS WERE POSITIONED AND THE PROXIMAL ANASTOMOSIS, AS WELL AS THE GATE AND THE LIMBS WERE BALLOON ANGIOPLASTIED TO GRAFT/STENT PROFILE AND VIA THE LEFT GROIN, A COMPLETION ANGIOGRAM WAS PERFORMED. THIS REVEALED THE PROXIMAL AND DISTAL LANDING ZONES TO HAVE A GOOD SEAL PERSEVERATION OF RENAL ARTERIAL FLOW. HOWEVER, JUST DISTAL TO THE SECOND COVERED STENT, THERE APPEARED TO BE A BLUSH AS WELL AS IN THE PROXIMAL LEFT LIMB OF THE ENDOGRAFT. UPON MAGNIFICATION WITH DIFFERENT ADDITIONAL VIEWS, IT APPEARED THAT THERE WERE, AT BOTH OF THESE LEVELS, DISRUPTION OF THE STENTS. VIA THE LEFT GROIN, A SECOND LIMB ZSLE WAS ADVANCED AND POSITIONED INSIDE OF THE LEFT LIMB IN ORDER TO SEAL OUT THE MOST DISTAL LEAK WHICH WAS PRESUMED TO BE FROM A STENT RUPTURE AND PRESUMED FABRIC TEAR. ONCE THIS WAS DEPLOYED, THIS WAS BALLOONED TO PROFILE. REPEAT ANGIOGRAPHY REVEALED THAT THIS DEFECT WAS SEALED SUCCESSFULLY AND UNEVENTFULLY. HOWEVER, THE MORE PROXIMAL LEAK INTO THE AORTIC ANEURYSM SAC REMAINED. THIS WAS AGAIN CONFIRMED BY ADVANCING TO THE AREA OF SUSPICION. A DIAGNOSTIC CATHETER AND ADDITIONAL ANGIOGRAPHY USING OBLIQUE AND CROSS TABLE VIEWS, APPEARED TO BE ON THE LATERAL ASPECT OF THE FABRIC, JUST INFERIOR TO THE SECOND COVERED STENT. THIS WAS ALSO PRESUMED TO BE A STENT FRACTURE WITH POSSIBLE FABRIC TEAR. FURTHER DISCUSSION WAS PERFORMED AND IT WAS DECIDED AT THIS POINT THAT ADDITIONAL ANGIOPLASTY AND STENTING WITH AORTIC CUFF WILL NOT RESULT IN A GOOD SEAL AND TO TREAT THIS FOR NOW MEDICALLY/CONSERVATIVELY AND WITH CLOSE FOLLOW-UP AND THIS LEAK MAY SEAL. THE PATIENT WAS REVERSED, EX-TUBATED, AND TRANSFERRED TO THE RECOVERY IN STABLE CONDITION. PATIENT WILL RETURN IN THE FUTURE TO HAVE THE STATUS OF THE LEAK OBSERVED. UPON FINAL RUN, A FABRIC TEAR WAS NOTED AND BELIEVED TO BE BETWEEN THE SECOND AND THIRD STENT ON THE RIGHT SIDE; TYPE III ENDO LEAK. PATIENT IS IN STABLE CONDITION AND WILL BE RETURNING IN THE FUTURE TO HAVE THE STATUS OF THE LEAK OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 589000 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |