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

Model Number	ENLW1624C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pain (1994); Rupture (2208)
Date of Event	12/13/2019
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 stent graft system was implanted in a patient for the endovascular treatment of an 87mm abdominal aortic aneurysm.It was reported that approximately 8 years and 7 months post index procedure the patient presented emergently with acute abdominal pain and hypotension, patient blood pressure upon arrival into operating suite was 57/46, resulting from a large distal type ib endoleak.A right retroperitoneal haemorrhage was identified on the angiogram.A right femoral artery exposure was completed and a distal 28 x 28 x 82 extension piece was placed to cover the ruptured area.Embolization of the right internal iliac artery was completed after the patient became normotensive.Extension of the graft was completed and extended into the right femoral artery.Balloon angioplasty and adjunctive stenting was completed.Final angiogram indicated successful exclusion of the leak.As per the physician, the cause of the event was due to losing the patient to follow up.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported distal type i endoleak leading to the rupture was confirmed; however, the exact cause of the endoleak could not be confirmed from the limited films provided.The anatomy at implant is unknown, the original implanted position of the devices is unknown, and ct¿s post-implant were not provided.It could not be confirmed if migration of the limb may have also contributed to the endo leak/rupture.It is possible that disease progression (iliac artery dilatation) and aneurysm morphology changes may have led to the endoleak and rupture.Lack of patient follow-up may have also been a contributor.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9488349
• Report Number: 9612164-2019-05218
• Device Sequence Number: 209539
• Product Code: MIH
• UDI-Device Identifier: 00613994761880
• UDI-Public: 00613994761880
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: 04/21/2013
• Device Model Number: ENLW1624C124E
• Device Catalogue Number: ENLW1624C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/11/2020
• 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: 76 YR
• Patient Weight: 78