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

Model Number	VAMC3632C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Pain (1994); Vascular Dissection (3160)
Date of Event	12/16/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant devices are: vamc3834c150tu, s/n: (b)(3); use by date: 2019-09-11; upn # (b)(4).Vamf4036c150tu , s/n: (b)(4); use by date: 2019-10-04; upn # (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant captiva stent graft system was implanted in a patient for the endovascular treatment of a 260mm length thoracic aortic dissection.Approximately 2 days prior to the index procedure, the patient had an open debranching of the aortic arch and during the index procedure the stent graft system was implanted in the thoracic aorta, from the innominate artery origin to the distal thoracic to treat a dissection with imh.Both procedures went well.The following day, the patient had sudden onset chest pain and was rushed to ct.The ct showed a retrograde dissection.Per the physician, the cause of the event is unknown.The patient died shortly after.
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the retrograde type a dissection could not be determined from the films provided.Films prior to implant were not available and the patient¿s previously reported dissection could not be assessed, and films during implant were also not available.Ct¿s returned from 1-day post-implant revealed that the patient had been implanted with 3 valiant stent grafts.The aortic arch had been debranched, and the devices were positioned proximally from near the level of the innominate artery, across the arch, and positioned distally to 2cm above the level of the celiac artery.Beginning near the proximal bare spring, a type a retrograde dissection was observed along the medial/left and inside curvature of the thoracic, extending to the aortic valve.Analysis of the returned films did not reveal any stent graft or anatomical anomalies that could explain the observed type a dissection.Although no clear stent graft issues were observed near the start of the dissection, it is possible that the interaction of the stent grafts implanted into a patient with a type b dissection thoracic may have led to the type a dissection.It is unclear if the aortic arch de-branching just prior to implant may have also contributed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7192849
• Report Number: 2953200-2018-00095
• Device Sequence Number: 1952074
• Product Code: MIH
• UDI-Device Identifier: 00643169346864
• UDI-Public: 00643169346864
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/09/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2019
• Device Model Number: VAMC3632C150TU
• Device Catalogue Number: VAMC3632C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 04/09/2018
• 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: Death
• Patient Age: 81 YR