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

Model Number	VNMC3428C207TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/08/2020
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 navion stent graft was implanted in the endovascular treatment of a 74mm thoracic aortic aneurysms.The month previously the patient had a aortic ascending repair utilizing the elephant trunk technique.A follow-up ct just over five weeks post the tevar procedure showed no endoleaks but the aneurysm had grown from 74mm to 80mm.It was reported the patient called complaining of back pain and scans performed over 3 months post the index procedure showed the aneurysm size was the same but contrast was seen in the sac.It was mentioned that it was thought to be a possible type ii endoleak because a type i endoleak could not be seen.Intervention was performed via open repair, a lot of clots were identified but there was no type i or type ii endoleak seen.The physician noted there was holes in the graft fabric where the sutures hold the nitinol stents to the graft fabric.One of the holes was ¿spraying¿ blood reportedly.It was also noted the valiant stent graft did not have a layer of tissue growth on it like the elephant trunk graft did.The valiant navion stent graft was then explanted.As per the physician the cause of the event was holes in the graft due to an unknown reason.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Product analysis conclusion 1; the reported contrast leakage into the aneurysm sac was confirmed on the films provided; however the type and cause of the endoleak could not be determined.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause.While a type iii fabric endoleak cannot be ruled out, analysis of the returned films did not reveal any obvious anatomical anomalies that may have led to the reported type iii endoleak, e.G.Calcification.A proximal or distal type i endoleak also appear to be unlikely from the films provided.The contrast leakage appears most possibly to have been a type ii endoleak from a collateral vessel.Product analysis conclusion 2; the navion graft had a slight angulation measuring approximately 20 degrees.No suture or nitinol breaks were observed during analysis of the graft.There was 1.19mm length weave separation observed on the 11th stent ring.Graft integrity issues were not identified through analysis.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.
Additional Manufacturer Narrative
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 NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 10885358
• Report Number: 9612164-2020-04555
• Device Sequence Number: 2882179
• Product Code: MIH
• UDI-Device Identifier: 00763000101237
• UDI-Public: 00763000101237
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2021

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: 09/09/2020
• Device Model Number: VNMC3428C207TU
• Device Catalogue Number: VNMC3428C207TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/26/2021; 02/19/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/12/2021; 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1201-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 53 YR