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

Model Number	ETEW2020C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for the endovascular treatment of a 51mm abdominal aortic aneurysm.It was reported that an endurant limb was used to extend a 1620x124 by 4cm into the left common iliac artery.It was reported that the physician ballooned the limb and an angiogram was performed.It was observed that a stenotic lesion approximately 15 mm proximal to the distal aspect of the extension limb had perforated/ruptured the vessel.The perforation/rupture was covered by an endurant cuff however a type iv endoleak was observed, with contrast slowly moving into the retroperitoneal cavity.The physician decided to re-line with another endurant iliac limb and this completely resolved the issue.The cause of the event, as per the physician, was anatomy related, due to the stenotic, calcified and thrombosed lesion.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Films review summary: the exact cause of the ruptured left iliac artery could not be determined from the pre-implant films provided.Images during implant were not provided and the reported events could not be assessed, and post-implant ct¿s were not provided.Pre-implant ct¿s revealed that the proximal neck was severely calcified and angulated ~85 deg rt-lt.The iliac arteries were non-tortuous but extensively calcified bilaterally.The left common iliac artery diameter ranged from 20 ¿ 17 ¿ 13mm along the 6cm length, and the left external artery diameter measured 6cm.It appears likely that ballooning within the small diameter, stenosed, and calcified vessel likely contributed to the vessel perforation.The reported type iv endoleak was likely caused by fabric porosity.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the 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: 7005494
• Report Number: 2953200-2017-01701
• Device Sequence Number: 11100837
• Product Code: MIH
• UDI-Device Identifier: 00613994991393
• UDI-Public: 00613994991393
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 11/28/2017

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: 07/18/2019
• Device Model Number: ETEW2020C82E
• Device Catalogue Number: ETEW2020C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 11/28/2017
• 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: 84 YR