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

Model Number	VAMC4242C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: vamc4242c150tu, serial/lot #: (b)(4), ubd: 25-oct-2019, udi#: (b)(4); product id: vamc4040c200tu, serial/lot #: (b)(4), ubd: 28-sep-2019, udi#: (b)(4); product id: vamf4040c200tu, serial/lot #: (b)(4), ubd: 25-oct-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 the endovascular treatment of a unknown sized ruptured abdominal aortic aneurysm.Another valiant captivia was then implanted 2 months later.It was reported on an unknown date after the index procedure, a type iiia endoleak between the 1st and 2nd component was diagnosed.A non mdt stent graft was used to treat this endoleak roughly 3 months after the index procedure.No cause was reported.No additional clinical sequalae were provided and the patient is fine.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12187215
• Report Number: 9612164-2021-02764
• Device Sequence Number: 14330055
• Product Code: MIH
• UDI-Device Identifier: 00643169346734
• UDI-Public: 00643169346734
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/19/2021

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: 04/16/2020
• Device Model Number: VAMC4242C200TU
• Device Catalogue Number: VAMC4242C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/19/2021
• 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