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

Model Number	VAMF4040C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	01/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: v amf4036c150tu, serial/lot #: (b)(4), ubd: 08-apr-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft was implanted in the endovascular treatment of a 80mm thoracic aortic aneurysm.Another valiant captiva stent graft was also implanted ten months later.It was reported that the patient presented emergently two years and eight months post the last implant with symptoms of a ruptured aneurysm.A ct was performed and showed an endoleak.It was reported that the physician believed this was a type iiia endoleak due to an inadequate overlap between graft pieces.This endoleak was treated and the patient was brought to or where another stent graft was implanted, this subsequently resolved the event.As per the physician the cause of the event was inadequate overlap between graft pieces.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported endoleak which may have contributed to the ruptured taa was confirmed; however, the exact cause/source of the endoleak could not be determined from the films returned.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy, and images during implant and at the intervention 10 months later were also not available.Lack of returned angiograms (including endoleak interrogation) also did not allow for a more comprehensive determination of the endoleak source/cause.While a type iiib fabric endoleak cannot be ruled out, this appears most likely to have been a type iiia junctional endoleak due to insufficient component overlap.The cause could not be determined.Since the amount of initial overlap is unknown it could not be determined if there was inadequate overlap at implant or if the overlap may have reduced during the implant duration; possibly due aneurysm morphology changes.A distal type ib endoleak was also seen which appears most likely to have been caused by disease progression; thoracic dilatation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9606908
• Report Number: 9612164-2020-00334
• Device Sequence Number: 14122706
• Product Code: MIH
• UDI-Device Identifier: 00643169346949
• UDI-Public: 00643169346949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/24/2020

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: 06/18/2017
• Device Model Number: VAMF4040C150TU
• Device Catalogue Number: VAMF4040C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/12/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/20/2020
• Supplement Report FDA Received Date: 02/24/2020
• 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: 68 YR