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

Model Number	ETCF3232C49E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/29/2019
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 endurant ii aortic cuff and 4 endurant limbs were implanted in an unknown stent graft system for the endovascular treatment of a ruptured 100mm abdominal aortic aneurysm with a type ia endoleak.It was reported that the patient presented to hospital emergently.A previous unknown stent graft was implanted in the patient.Ct revealed a ruptured aaa and type ia endoleak with extravasation.The physician realigned the unknown stent graft with the endurant ii aortic cuff and 4 endurant limbs however the type ia endoleak remained.Endoanchors were then implanted to gain seal however the type ia endoleak persisted.A repeat ct showed extravasation within the aaa sac, so the physician elected to convert to open repair and sutured the proximal portion of graft with success.The endoleak was confirmed as resolved.The patient was reported as doing well one day post procedure.Per the physician the cause of the rupture and type ia endoleak was anatomy related due to infrarenal neck dilation.It was reported that the extravasation noted on repeat ct was related to the pre-op rupture and not related to the medtronic devices.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
24-off-label, unapproved or contraindicated use (device implanted in a pre-operatively ruptured anuerysm).If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8730047
• Report Number: 9612164-2019-02512
• Device Sequence Number: 2572397
• Product Code: MIH
• UDI-Device Identifier: 00613994991454
• UDI-Public: 00613994991454
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: 03/25/2021
• Device Model Number: ETCF3232C49E
• Device Catalogue Number: ETCF3232C49E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 09/03/2019
• 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: Required Intervention
• Patient Age: 89 YR