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

Model Number	VAMF3232C100TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Vascular Dissection (3160)
Date of Event	01/07/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: (catalog number vamc3434c200tu, serial (b)(4), use by date 2019-03-07 and (b)(4) and catalog number vamc3232c200tu, serial (b)(4), use by date 2019-09-05 and (b)(4)).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 31 mm diameter 320 mm in length thoracic dissection.It was reported that the patient passed away post operatively.Per the physician the cause of death was not device related and due in part to complications of a connective tissue disorder the patient had a medical history of.The results from the autopsy revealed a retrograde type a dissection (previously not observed on final imaging during index procedure) with pericardial hematoma.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the retrograde type a dissection and patient¿s death could not be determined from the limited films provided.Pre-implant ct¿s and additional images during implant were not available for return.Analysis of the returned films did not reveal any anatomical or stent graft characteristics that could explain the reported events.The cause of death may have been related to a patient condition or unknown complication during the implant procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received; the date of the rtad was noted to be 3 days after the index procedure.The patient was reported to have originally have been treated for an intramural hematoma also and expired a day later than previously reported.Age of patient at time of event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7237104
• Report Number: 2953200-2018-00177
• Device Sequence Number: 11017312
• Product Code: MIH
• UDI-Device Identifier: 00643169347076
• UDI-Public: 00643169347076
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2018

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: 09/26/2019
• Device Model Number: VAMF3232C100TU
• Device Catalogue Number: VAMF3232C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 01/13/2018
• Supplement Date Received by Manufacturer: 02/13/2018; 07/05/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 03/01/2018; 07/11/2018
• 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: 57 YR