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

Model Number	ETCF3232C49E
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: etcf2828c49e, serial/lot #: (b)(4), ubd: 14-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Talent and aneurx stent grafts were implanted in the patient for an endovascular treatment.An endurant limb was additionally implanted approximately 138 months post index procedure, an endurant ii aortic cuff extension was to be implanted treatment of a type 1a endoleak.It was reported that during the index procedure, it was difficult to position two endurant ii aortic cuff extensions.It was stated that the devices bent when trying to access.As per the physician, cause of the event was patient's anatomy.It was reported that the patient had a highly torturous anatomy in the common and external iliacs artery.No additional clinical sequalae were reported and the patient will be monitored.

• 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 ; IE
• MDR Report Key: 10586248
• Report Number: 9612164-2020-03635
• Device Sequence Number: 11457929
• Product Code: MIH
• UDI-Device Identifier: 00613994991454
• UDI-Public: 00613994991454
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/25/2020

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: 06/03/2022
• Device Model Number: ETCF3232C49E
• Device Catalogue Number: ETCF3232C49E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR