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

Model Number	VAMF3434C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Pain (1994)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: v amc3834c150tu, serial/lot #: (b)(4), ubd: 08-feb-2020, udi#: (b)(4); product id: vamc3632c150tu, serial/lot #: (b)(4), ubd: 05-mar-2020, udi#: (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 thoracic endovascular treatment of a complicated type b dissection.It was reported that the following morning the patent experienced pain and a ct scan identified a retrograde type a dissection.The physician performed further surgery.An ascending aorta and aortic arch replacement was carried out with debranching of the innominate and left carotid arteries.The treatment was successfully completed and the event was resolved.Per the physician, the cause of the event was due to patient anatomy-complicated acute type b dissection.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the retrograde type a dissection could not be determined from the films provided.Review of pre-implant ct¿s revealed that the patient had a thoracic dissection that extended continuously (and spiraling) from just caudal to the lsa and distally into both iliac arteries.The flow lumen diameter of the ascending thoracic measured ~32mm.The true lumen (tl) diameter was extremely varied and was spiraling; measuring ~20mm in diameter just past the lsa, 14mm at the mid-descending, and narrowed down to 8mm x 18mm at the distal extent of the descending thoracic.No aortic calcification was observed, with the exception of near the mid-abdominal aorta and left iliac artery bifurcation.Ct¿s returned from 1-day post-implant revealed that the patient had been implanted with 3 valiant stent grafts, which were positioned from just caudal to the left common carotid artery, extending across the arch and into the descending thoracic to ~10mm above the celiac artery.The ascending thoracic had dissected and the descending thoracic dissection appeared covered.The devices were patent, with no obvious stent graft kinks or unusual compression observed.The visceral vessels, abdominal aorta and both iliacs were all patent.Images during implant were not available for return.It is possible that the patient¿s pre-existing condition of a complicated type b dissection, or a procedural issue, may have led to the type a dissection seen shortly post-implant.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: 7929362
• Report Number: 2953200-2018-01387
• Device Sequence Number: 2269481
• Product Code: MIH
• UDI-Device Identifier: 00643169346970
• UDI-Public: 00643169346970
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/09/2018

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: 10/31/2019
• Device Model Number: VAMF3434C150TU
• Device Catalogue Number: VAMF3434C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 95