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

Model Number	VAMF4040C100TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: v amf4040c200tu, serial/lot #: (b)(4), ubd: 28-jun-2017, 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 60mm * 100mm thoracic aortic aneurysm.It was reported that approximately 4 years and 10 months later the patient presented with back pain and a type ia and ib endoleak was observed on ct.Intervention was performed the next day, the physician implanted a vnmf4343c103e, it was reported there was great difficulty positioning this device due to severe tortuosity.Due to the severe angulation the tip capture mechanism would not release so the physician performed the non release tip capture mechanism in order to deploy the bare spring.As per the physician the cause of the event was anatomy and due to disease progression of the distal aorta.No additional clinical sequelae were provided and the patient is fine.
Additional Manufacturer Narrative
The reported endoleak was confirmed on the film provided; however the cause or type of endoleak could not be confirmed.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen, and only a single imaging view point (a-p) was observed in the films provided; thereby, making determination of the endoleak difficult.It appears that a type ia and type ib endoleak did occur from the limited images provided and it is likely that disease progression over the 5 year implant period may have contributed to this event.Angiogram videos during implantation of the valiant navion were not provided so the positioning difficulties reported to have occurred could not be assessed but it is possible that the angulation noted in the descending aorta was a factor in the tip capture mechanism issues.Analysis of the returned videos did not reveal any out of specification stent graft integrity issues.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: 10229182
• Report Number: 9612164-2020-02412
• Device Sequence Number: 3195071
• Product Code: MIH
• UDI-Device Identifier: 00643169347359
• UDI-Public: 00643169347359
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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: 10/25/2015
• Device Model Number: VAMF4040C100TU
• Device Catalogue Number: VAMF4040C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2020
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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: 87 YR