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

Model Number	VAMF3434C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant devices are: catalogue # vamc4242c200tu, serial # (b)(4), use by date: 2019-05-15, upn: (b)(4); catalogue # vamf3838c100tu, serial # (b)(4), use by date: 2018-10-19, upn: (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a 5.5 cm thoracic aortic aneurysm.It was reported that the patient present emergently with chest pain.A ct showed that there was an unknown endoleak, either a type i endoleak or a type iii separation endoleak.The physician elected to implant two additional valiant stent grafts, modeled the stent grafts with a balloon and the unknown endoleak was resolved.The physician stated that the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
For system reported catalogue # vamf3838c100tu, serial # (b)(4), use by date: 2018-10-19, upn: (b)(4).Failure to follow instructions bare spring implanted within another device film evaluation summary: the cause of the unknown endoleak could not be determined from the films provided.Angiograms returned during implant revealed that 2 valiant stent grafts were implanted, positioned from just distal to the lca, and extending across the arch and into the descending thoracic.Final angio showed an unknown endoleak from just above the junction with the distal device.An additional short freeflo device was then seen implanted across both main devices overlapping the area of the previously seen endoleak.Final angio showed a reduction but unlikely complete resolution of the endoleak.Ct¿s 2-days later again showed contrast around the perimeter of the stent grafts, along nearly the entire length of the taa.Same day angiograms showed that 2 additional 200mm length valiant stent grafts had been implanted within the three (3) initially implanted devices; and the previously seen endoleak appeared to have resolved.Angio injections prior to implanting were not seen in the films.The exact source/type of endoleak could not be determined.This appears most likely to have been a late type iv caused by fabric porosity, but cannot rule out a proximal type i endoleak or a type iii fabric endoleak.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: 6844243
• Report Number: 2953200-2017-01400
• Device Sequence Number: 44526
• Product Code: MIH
• UDI-Device Identifier: 00643169347366
• UDI-Public: 00643169347366
• 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): 10/27/2017

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: 04/05/2019
• Device Model Number: VAMF3434C200TU
• Device Catalogue Number: VAMF3434C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 08/13/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: 72 YR