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

Model Number VAMF4646C200TE

Device Problem Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2024

Event Type  Injury  

Event Description

Two valiant captivia stent grafts were implanted during the endovascular treatment of a 50mm taa.It was reported that during the index procedure the patient underwent total endovascular repair of the thoracic aortic aneurysm.  va mf4444c200te was used as the proximal stent.There was no endoleak noted during angiography but the distal anchoring area was insufficient so vamf4646c200te was implanted distally.An angio then showed a type iiib endoleak occurred where the grafts were connected.The proximal stent was punctured by the bare stent of the distal graft vamf4646c200te.A non-mdt stent graft was implanted and the endoleak was resolved.Per the physician the cause of the endoleak was caused as one of the bare stents of the distal vamf4646c200te punctured the proximal stent graft vamf4444c200te.No additional sequelae were reported and the patients is fine.

Manufacturer Narrative

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.

Manufacturer Narrative

Film evaluation summary: the reported device damaged by another device leading to an endoleak could not be fully confirmed on the films provided.Additional angiogram videos showing the exact moment of deployment of both stent grafts were not available for review.Endoleak interrogation via selective angiograms (i.E.Injecting contrast from several levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen.There is a possibility that this was an acute type iii fabric endoleak possibly caused by an interaction between the bare stents of the distal valiant captivia stent graft with the fabric of the proximal stent graft in the overlapping area, leading to abrasion and subsequent fabric puncture/ tear, butthis could not be confirmed.A type iv endoleak cannot the fully ruled out, but seems unlikely.No endoleak was visible after the implantation of the proximal stent graft and was observed only after the implantation of the distal device.Both valiant captivia models have a freeflo proximal end configuration, which consists of an 8-peak proximal bare stent with mini support spring.The proximal bare stents extend past the proximal edge of the fabric to provide additional fixation while maintaining transvessel flow.The instructions for use (ifu) of the valiant captivia states that "the bare stent should never be placed inside another section".The stent model vamf4444c200te was implanted first, proximally within the thoracic aorta, followed by the implantation of vamf4646c200te distally, indicating that the bare stents of vamf4646c200te were placed within the vamf4444c200te in the overlapping zone.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.

Manufacturer Narrative

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 - FF
• Type of Device: 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: 18934037
• MDR Text Key: 338032463
• Report Number: 9612164-2024-01317
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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
• Device Operator: Health Professional
• Device Model Number: VAMF4646C200TE
• Device Catalogue Number: VAMF4646C200TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male