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

Model Number	ETBF2816C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/26/2018
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 stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.It was reported that approximately 6 years post the index procedure a ct was performed showing a type ia endoleak.It is noted that the patient had disease progression with no endovascular treatment option and the physician decided to convert to open surgery and explantation and the event was resolved.As per the physician, the cause of the event was anatomy related; due to the disease progression.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: examination of the returned devices revealed four (4) holes around the perimeter of the aortic body, between covered stent rings #1 & 4.Three (3) of the holes ranged in size from 0.36 ¿ 0.56 mm²; however, a 3.8 mm² abrasion hole was also seen along the anterior of the proximal bifurcate between stent rings #1 & 2 which may have contributed to a potential type iii fabric endoleak.The cause of the holes appeared most likely to be abrasion related due to external calcification, or due to abrasion from the stents seen adjacent to the holes.Two (2) additional holes, 0.22 mm² & 1.06mm² in size, were also see along the posterior side of the ipsilateral limb origin (stent ring #5) just below the level of the flow divider.The exact cause of these two holes is unknown but appeared most likely due to stent abrasion that may have been exacerbated by the observed a-p limb angulation.It is possible that these additional holes may have been the source of a type iii fabric endoleak; however, the bifurcate aortic body id appeared ¿covered¿ by a ~1 mm thick layer of organized thrombus/tissue, which may have sealed the smaller holes found between rings #1 & 4.A large amount of tissue was also observed attached to stent graft od near the ipsilateral limb origin, which also may have sealed the two holes seen near ring #5.Other than several cut sutures around the aortic body likely associated with the abrasion holes noted above, no other device integrity issues were observed with the bifurcate, and no issues were seen with the returned proximal sections of the contralateral limb and ipsilateral limb extension.Film review: pre-implant ct¿s and films just prior to explant were returned.From the analysis of the returned films the primary cause of the proximal type i endoleak appears most likely due to disease progression; neck dilatation.Pre-implant ct¿s revealed that the patient had a 57 mm max diameter infrarenal aaa.The proximal neck was long (~4 cm), contained irregular-shaped thrombus with scattered calcification, and the infrarenal neck was severely angulated ~70° a-p.The neck diameter ranged from 21 ¿ 23 ¿ 19 mm along a 30 mm length.Returned ct¿s from 67 months post-implant revealed that the patient¿s infrarenal aneurysm was bi-lobal shaped; the proximal aaa diameter was 47 mm and the distal aaa diameter measured 43 mm.There was a proximal type i endoleak due to lack of a proximal neck most likely caused by disease progression.The aortic diameter near the level of the sma had increased from 19 to 26 mm.The bifurcate was positioned below the renal arteries and the neck diameter had dilated to ~40 mm at the bifurcate proximal margin.The infrarenal neck and aortic body were angulated at the flow divider ~75° a-p relative to the distal aorta.Although no type iii fabric endoleak was reported by the physician during the explant or observed on the returned films, the calcified and angulated neck may have led to the abrasion holes observed from the explant examination, which in addition to the proximal type i endoleak may have also contributed to the aneurysm expansion.If information is provided in the future, a supplemental report will be issued.

• 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: 7361049
• Report Number: 2953200-2018-00404
• Device Sequence Number: 16462126
• Product Code: MIH
• UDI-Device Identifier: 00613994991317
• UDI-Public: 00613994991317
• 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
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 05/28/2014
• Device Model Number: ETBF2816C124E
• Device Catalogue Number: ETBF2816C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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: 74 YR