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

Model Number	VAMC4440C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other medical products in use during the event include: brand name: valiant captivia - cw; product id: vamc3434c150tu (serial: (b)(6); product type: 0180-aortic stent graft; implant date: (b)(6) 2024.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.
Event or Problem Description
Valiant captivia stent grafts were implanted during the endovascular treatment of a 82mm taa.It was reported that a follow-up ct taken one week after the index procedure showed a potential delayed endoleak, however due to the contrast timing delay and separation of chest and abdomen scans, the cause and location of the leak was unable to be properly identified.It was noted that the minimum overlap of the distal tapered 44x40x150 stent graft into the distal straight 34x34x150 stent graft was demonstrated on the ct taken on that date.The patient was scheduled for surgery and an angiogram was performed 11 days after the index procedure, which identified a type iiia endoleak between the 2 valiant captivia stent grafts.Another valiant captivia stent graft was implanted to bridge the type iiia endoleak.The final angiogram showed no endoleak.Per the physician, the cause of the endoleak is undetermined.It was noted that the endoleak appeared in spite of appropriate oversizing in an unsupported junction as well as achieving minimum overlap.No additional sequelae were reported and the patients is fine.
Additional Manufacturer Narrative
Product analysis conclusion: the reported type iiia endoleak could not be confirmed on the pre-implant films provided; therefore the cause of the event could not be determined.Lack of post-implant cts and angiography images showing the endoleak, which may have included possible endoleak interrogation, did not permit a more comprehensive analysis of the endoleak source/cause.It is possible that the severely angulated thoracic aorta may have may have contributed to the reported endoleak, but this could not be confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18865244
• Report Number: 9612164-2024-01178
• Device Sequence Number: 8240016
• Product Code: MIH
• UDI-Device Identifier: 00643169346697
• UDI-Public: 00643169346697
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: 10/15/2025
• Device Model Number: VAMC4440C150TU
• Device Catalogue Number: VAMC4440C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 64 KG