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

Model Number	VAMF3636C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Intimal Dissection (1333); Aneurysm (1708); Stroke/CVA (1770)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the patient for endovascular treatment of a 350mm aortic dissection.It was reported approximately 5 years post the index procedure, the patient presented with a stroke.A ct showed that the previously resolved aortic dissection had extended distally and was filling the false lumen from the distal portion of the aorta, causing a 65mm aneurysm expansion into the descending aorta.Intervention was carried out on this date with the implantation of a 38x38x200 valiant to extend just above the celiac artery.An angiogram showed there was no filling of the false lumen from the distal aorta, however, there was filling from the proximal end of the aorta which was confirmed as a type ia endoleak.It was noted there was 7mm space from the left subclavian to the beginning of the stent graft material and 2.5cm from the left carotid.An intervention was completed where the physician performed a left carotid to left subclavian bypass and placed a v07585749 up to the left carotid.After the implant the endoleak was not observed.The cause of the event as per the physician was degeneration of the aorta over time.No additional clinical sequalae were reported and the patient is fine.
Additional Manufacturer Narrative
Image review: the cause of the events could not be determined from the limited films returned.The anatomy at implant is unknown, and earlier post-implant films were not available for review.In addition, no images were returned showing the descending thoracic, including films during the intervention of the reported distal extension of the aortic dissection that led to aneurysm expansion into the descending aorta.The cause of the reported stroke, distal filling of the previously covered dissection leading to the aneurysm expansion into the descending aorta, and the proximal type i endoleak, could not be determined from the films provided.It is possible that the patient¿s reported medical history of a prior stroke and previously treated dissection, along with continued disease progression, may have contributed to the events.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7633250
• Report Number: 2953200-2018-00882
• Device Sequence Number: 2376312
• Product Code: MIH
• UDI-Device Identifier: 00613994797964
• UDI-Public: 00613994797964
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2015
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 08/08/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/03/2018
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 127