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

Model Number UNK-CV-SR-VAL-CAP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; application of an extracorporeal pre fenestrated stent graft in endovascular repair of ascending aorta and aortic arch lesions wang l, bai l, zhang y, liu j <(>&<)> li x.Vascular 0(0) 1¿7 doi: 10.1177/1708538120950876.If information is provided in the future, a supplemental report will be issued.

Event Description

A pre-fenestrated valiant captivia stent graft was implanted in the endovascular treatment of an aortic dissection with an entry tear located in zone 3 and slotting in the lca.A retrograde type a dissection (rtad) was observed two weeks after surgery.The patient was then treated by embolization of the ascending aortic false lumen with non mdt coils, resulting in a decrease in contrast agent density in the postoperative ct angiography.Postoperative follow-up showed that no ascending aortic dissection had developed.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received; it was noted that the rtad may have been related to the bare stent.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: VALIANT CAPTIVIA UNK
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10755112
• MDR Text Key: 213658365
• Report Number: 9612164-2020-04137
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-VAL-CAP
• Device Catalogue Number: UNK-CV-SR-VAL-CAP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR