MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETBF2816C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: etlw1610c93e, serial/lot #:(b)(4), ubd: 11-jun-2020, udi#: (b)(4); product id: etlw1610c156e, serial/lot #: (b)(4), ubd: 19-jun-2019, udi#: (b)(4); product id: etlw1613c156e, serial/lot #: (b)(4), ubd: 20-nov-2020, udi#: (b)(4).Film evaluation summary: the exact cause of the reported left limb occlusion could not be determined from the films provided.Pre-implant films were not pro vided, angiograms at implant and earlier follow-up¿s were not available for review, and the blood flow dynamics could not be assessed from the ct¿s provided.The returned films were non (or very low) contrast; therefore, the reported occlusion could not be confirmed.Other than the moderate angulation observed in both iliac limbs, analysis of the returned films did not reveal any anatomical or stent graft characteristics that could explain the reported event.No obvious stent graft kinks or areas of compression were noted, and the minimum stent graft id within the iliac limbs measured ~8 mm on the right and 7 mm on the left.The limb occlusion may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.The reason for (b)(6) intervention where an aortic cuff, endoanchors, and two iliac limbs were implanted, also could not be determined from the films provided.Pending return of additional information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.It was reported approximately 6 years post the index procedure, an additional endurant cuff, limbs and heli-fx endoanchors were implanted prophylactically due to the patient presenting with abdominal pain.It was confirmed that there was no sign of endoleak and it is unconfirmed if the aneurysm had continued to grow.The physician decided to proceed with re-lining of the existing stent graft and to place endoanchors proximally as a precautionary measure in case the patients symptoms were related to the aneurysm.It was reported 9 months post the index procedure, follow up ct identified an occluded left limb.The physician elected to treat the occlusion of the limb with a fem-fem bypass and the patient is doing well.Per the physician the cause of the event is undetermined.No additional clinical sequelae were reported and the patient will be monitored.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8792345
• Report Number: 9612164-2019-02865
• Device Sequence Number: 1707860
• Product Code: MIH
• UDI-Device Identifier: 00613994991133
• UDI-Public: 00613994991133
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: ETBF2816C166E
• Device Catalogue Number: ETBF2816C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 59