ENDURANT II ILIAC STENT GRAFT
Report
- Report Number
- 9612164-2024-03216
- Event Type
- Malfunction
- Date Received
- July 12, 2024
- Date of Event
- July 9, 2024
- Report Date
- September 18, 2024
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THERE WAS NO DAMAGE NOTED TO THE GRAFT COVER OR DELIVERY SYSTEM PRIOR TO INSERTION AND THE INSTRUCTIONS FOR USE (IFU) FOLLOWED WHEN DEPLOYING THE LIMB. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
PRODUCT ANALYSIS CONCLUSION: THE DEVICE RETURNED WITH THE EXTERNAL SLIDER PARTIALLY RETRACTED. A GAP WAS OBSERVED BETWEEN THE TAPER TIP AND THE GRAFT COVER/STENT GRAFT. A SEVERE KINK WAS VISIBLE ON THE SPIRAL TUBING AT THE GRAFT COVER TIP. A BEND WAS VISIBLE ON THE GRAFT COVER/STENT STOP. STRETCHING WAS VISIBLE AT THE END OF THE GRAFT COVER TRANSITION BOND. THE DISTAL STENT GRAFT RING WAS PARTIALLY OVERLAPPING THE STENT STOP CUP. TWISTING WAS OBSERVED ON THE GRAFT COVER AT THE STENT STOP CUP. ON ROTATION OF THE EXTERNAL SLIDER THE STENT GRAFT RETRACTED WITH THE GRAFT COVER AND COULD NOT BE DEPLOYED. THE STENT GRAFT WAS MANUALLY DEPLOYED. THE GRAFT COVER ID WAS MEASURED AT 0.189-INCH; SPECIFICATION IS 0.190-INCH MINIMUM INDICATING THE RO MARKER BOND SITE WAS SLIGHTLY SMALL. DEFORMATION WAS VISIBLE TO THE STENT STOP CUP MATERIAL DUE TO THE STENT GRAFT RING OVERLAPPING. THE REPORTED DEPLOYMENT/EXPANSION ISSUE WAS CONFIRMED THROUGH ANALYSIS. PIN GAUGES CAL # 1240049 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
FILM EVALUATION SUMMARY: THE DEPLOYMENT DIFFICULTIES COULD NOT BE FULLY ASSESSED ON THE PRE-IMPLANT CTS PROVIDED; THEREFORE, THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED. PROCEDURAL ANGIOGRAMS SHOWING THE DEVICE BEING INTRODUCED INTO THE PATIENT AND DEPLOYMENT ATTEMPTS WERE NOT AVAILABLE FOR ASSESSMENT OF THE REPORTED EVENT. ALTHOUGH THE ANALYSIS OF THE RETURNED FILMS DID NOT REVEAL ANY OTHER OBVIOUS ANATOMICAL CHARACTERISTICS THAT COULD HAVE CONTRIBUTED TO THE GRAFT COVER BEING STUCK OVER THE STENT GRAFT, THE PRESENCE OF A LIKELY PAU/DISSECTION IN THE PROXIMAL HALF OF THE RIGHT COMMON ILIAC ARTERY MAY HAVE BEEN A CONTRIBUTORY FACTOR TO THE REPORTED EVENT, BUT THIS COULD NOT BE CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
AN ENDURANT II STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC PAU. IT WAS REPORTED ON DURING THE INDEX PROCEDURE, THE IPSI LIMB ETLW1616C156EE WAS DEPLOYED VIA A 16FR SENTRANT SHEATH BUT THE GRAFT WAS FOUND TO BE NOT MOVING ON ANGIO EVEN THOUGH EXTERNAL SLIDER HAD ROLLED HALFWAY DOWN THE SCREW GEAR. UPON REMOVAL FROM BODY, IT WAS FOUND THAT THE GRAFT COVER WAS STUCK OVER THE STENT GRAFT AND SQUEEZED IT INSIDE THE GRAFT COVER INSTEAD OF SLIDING OVER THE STENT GRAFT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE LIMB. PER THE PHYSICIAN THE CAUSE WAS DETERMINED TO BE DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 275317 | ENDURANT II ILIAC STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | ETLW1616C156EE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |