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

Model Number	ETLW1610C156E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914)
Date of Event	09/23/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a left common iliac aneurysm and ectatic right common iliac.It was reported during the index procedure after the stent graft was deployed, final angio showed a good result and the patient was taken to sicu post-op.It was reported two hours post transfer the patient became hypotensive and coded.The patient was transferred to the cath lab where cpr was in process.An angio showed a ruptured right external iliac, it was unclear were the rupture was so an etlw1610c156e (b)(4) was implanted to cover the right hypogastric and extended into the external iliac.The bleeding was gotten under control however the patient had lost too much blood and had been getting cpr and resuscitated for an hour at this time.The physician decided to stop and pronounced the patient deceased.Per the physician the cause of the death was due to the ruptured external iliac that was not visualized on the completion angiogram.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10682748
• Report Number: 9612164-2020-03932
• Device Sequence Number: 14243614
• Product Code: MIH
• UDI-Device Identifier: 00643169467637
• UDI-Public: 00643169467637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2021
• Device Model Number: ETLW1610C156E
• Device Catalogue Number: ETLW1610C156E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/15/2020
• 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: Death; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 84