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

Model Number	ETLW1610C156E
Medical Device Problem Codes	Device Damaged by Another Device (2915); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
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 attempted to be implanted in the patient.It was stated that the patient had a previous non medtronic stent in his external iliac and a endurant iliac stent in his common iliac artery and the patient's external iliac was starting to pull up towards the patient's external.Therefore, the physician decided to bridge the endurant stent and the stent in the external with another endurant iliac stent.It was reported that during the index procedure, difficulties to advance the device into the patients common iliac artery was encountered, several attempts were performed without success.The physician then decided to pull the device, but once the device was outside the patient difficulties to pull the delivery system back was also encountered.The physician deployed the stent graft outside of the patient and where it was noted that the guide wire was crimped.And this was thought to be the reason for the device advancing issue.The procedure was successfully completed with another endurant stent graft and a new guide wire.As per the physician, cause of the device advancing difficulty was user error.No additional clinical sequalae were reported and the patient is fine.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12273254
• Report Number: 9612164-2021-02990
• Device Sequence Number: 19735872
• Product Code: MIH
• UDI-Device Identifier: 00643169467637
• UDI-Public: 00643169467637
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2021
• 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: 07/07/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR