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

Model Number	VAMF3636C200TU
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Rupture (2208); Embolism/Embolus (4438)
Date of Event	12/05/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant navion stent grafts were implanted in the endovascular treatment of a 65.4mm ruptured thoracic aortic aneurysm.It was reported over 7 years later, the patient presented to er.A ct revealed an increase in aneurysm size likely due to a type iii endoleak.Two days later , an urgent tevar procedure was performed.The physician stated it was believed the bare stent of the vamf3636c200tj had eroded through the fabric of the vamf4444c200tu stent graft causing the suspected type iii endoleak.During the intervention a valiant navion was implanted to cover the tear and endoleak was resolved following its deployment.The patient survived the procedure, but post-operatively developed a clot in the right lung which a test tube was unable to clear.The patient became acidotic and expired on an unknown date.It was said the physician in consultation with the patients family decided to forgo routine follow-up scans for this patient 3 years previously as there was no further endovascular testament options available and it was known the patient was unlikely to survive an open repair.As per the physician the cause of the iiib endoleak was the bare stent of the distal device eroding the fabric of the proximal device.No additional clinical sequalae were provided and the patient is expired.
Additional Manufacturer Narrative
It was reported the physician stated that the clot in the right pleural cavity was the result of a ruptured aorta.He stated that the er had contemplated chest tube insertion upon presentation in the unit but realized the potential fatal impact it would have caused prior to sealing the leak.Correction: valiant captiva stent grafts were implanted in the endovascular treatment of a 65.4mm ruptured thoracic aortic aneurysm on the (b)(6) 2013.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
H:6 conclusion code updated.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.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11018174
• Report Number: 9612164-2020-04937
• Device Sequence Number: 753618
• Product Code: MIH
• UDI-Device Identifier: 00613994797964
• UDI-Public: 00613994797964
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2021

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: 11/20/2014
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/16/2020; 01/14/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/11/2021; 01/20/2021
• 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; Required Intervention
• Patient Age: 88 YR