MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	VAMF4040C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: vamc4036c150tu, serial/lot #: (b)(4), ubd: 10-aug-2018, udi#: (b)(4).Product id: vamc4646c150tu, serial/lot #: (b)(4), ubd: 05-apr-2018, udi#: (b)(4).Product id: vamc4040c150tu, serial/lot #: (b)(4), ubd: 29-aug-2019, udi#: (b)(4).Product id: vamc4242c150tu, serial/lot #: (b)(4), ubd: 24-jul-2019, udi#: (b)(4).Product id: vamf4040c200tu, serial/lot #: (b)(4), ubd: 15-may-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant captivia stent grafts were implanted in a patient for the endovascular treatment of an 83mm in diameter thoracoabdominal aortic aneurysm (taaa).A further 3 valiant captivia stent grafts were implanted seven months later.It was reported the patient presented emergently approximately 3.5 years post index procedure with chest and back pain.A ct performed showed a possible iiib endoleak in the proximal component and the distal stent graft had minimal overlap with partial separation.It is unknown which devices were implanted proximally and distally.It was thought the iiib endoleak appeared to be at the junction of a non mdt (gore) stent graft and an unknown valiant captivia stent graft.The distal separation endoleak was between 2 valiant captivia stent grafts (exact devices unknown).Intervention was performed on the same date, a vnmc4646c175tu was implanted in the distal segment of the graft to cover the separation.A vnmf4646c182tu stent graft was implanted to cover proximal overlap and possible graft hole.This resolved the endoleaks.As per the physician the cause of the event cannot be determined.No additional clinical sequelae were provided and the patient is fine.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10572384
• Report Number: 9612164-2020-03565
• Device Sequence Number: 1271003
• Product Code: MIH
• UDI-Device Identifier: 00643169346543
• UDI-Public: 00643169346543
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2018
• Device Model Number: VAMF4040C200TU
• Device Catalogue Number: VAMF4040C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/23/2020
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 61