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

Model Number	ETTF3636C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/24/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An aneurx stent graft system bfxch2816165 was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm on (b)(6) 2009.Aneurysm and vessel morphology from the time of implant were not reported.It was reported that during a follow-up approximately 1 week later, the physician noticed that the aneurx stent graft had migrated due to the aortic neck expansion where the neck measures 28 mm at the renals and 15 mm below it was 32 mm with a proximal type ia endoleak present.After doing an angiogram there was 8+ cm's from the renal arteries to the bifurcation of the previously implanted aneurx stent graft.It was decided to treat the patient with endurant cuffs.A 32/32/49 endurant cuff was placed first followed by a 36/36/70 endurant cuff to reach the renal arteries.Four aptus anchoring pins were then placed in the proximal portion of the 36/36/70 cuff.After angio the proximal part was sealed but it appeared that there was insufficient overlap between the cuffs and the previous stent graft.It was confirmed there was no endoleak between the endurant cuffs just not enough overlap.A third 36/36/49 cuff was then placed at the bifurcation of the aneurx stent graft and a good seal was obtained.No clinical sequelae were reported and the patient is fine.It was reported that approximately 10.5 years post index procedure a ct scan and an aorta gram on showed a type ia endoleak.An intervention procedure was carried out and an additional 36x36x49 endurant ii cuff was implanted to the level of the sma.The right renal artery was cannulated prior to deployment of the cuff so a stent could be placed to snorkel the renal above the graft.There was no left renal artery.A 7x39 stent was placed in the renal artery with access from the left brachial artery.At the same time the stent was deployed the endurant ii cuff was also placed and deployed.Both the stent and cuff were ballooned simultaneously.An aorta gram was performed, and the leak was no longer present.The renal artery was also perfusing.The procedure was then completed.No clinical sequelae were reported and the patient is fine.It was reported that the cause of the type ia endoleak was due to continued neck dilation.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10188287
• Report Number: 9612164-2020-02305
• Device Sequence Number: 908765
• Product Code: MIH
• UDI-Device Identifier: 00613994991515
• UDI-Public: 00613994991515
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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: 09/16/2016
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/24/2020
• 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: Required Intervention
• Patient Age: 71 YR