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

Model Number	VAMC4642C150TU
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B5;additional information received: it was reported that there was no damage noted to the delivery system or packaging during unboxing.The deployment steps were followed per the instructions for use (ifu).The valiant captivia was released but then migrated distally to an unintended location due to the interaction with the previous open repair stent.It caught the kink in the open graph.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.
Additional Manufacturer Narrative
Film evaluation summary: the reported "deployment/expansion issue" and " device or device component damaged by another device " was confirmed on the still images provided; however, the exact cause of the event could not be determined on the limited films provided.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy as a potential factor.Procedural angiograms showing deployment of the stent graft were not received for a thorough analysis of the event.It is possible that the previously implanted surgical graft (which could not be fully visualized on the films received) did contribute to the deployment issue , but this could not be fully 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.
Additional 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.
Event or Problem Description
Valiant captivia stent grafts were implanted during the endovascular treatment of a thoracic aortic dissection.The proximal thoracic aorta diameter at implantation measured 40mm, with the dissection spanning a length of 20mm.It was reported during the index procedure, that the tapered portion of the valiant captivia (vamc4642c150tu) stent graft was delivered near a fold in the existing open graft repair.During deployment, the inner curve of the device initially made contact with the inner curve of thewall, the stent graft was then released and rotated distally.A long stent graft (46x200) piece was successfully placed and seal was achieved.Per the physician the cause of the deployment issue was anatomy related.It was suspected that the device may have initially deployed in contact with the graft fold before release and rotation.No additional clinical sequelae were provided, and the patient is fine.

• 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: 19371984
• Report Number: 9612164-2024-02470
• Device Sequence Number: 7619144
• Product Code: MIH
• UDI-Device Identifier: 00643169346680
• UDI-Public: 00643169346680
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Followup
• Report Date (Section B): 07/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2025
• Device Model Number: VAMC4642C150TU
• Device Catalogue Number: VAMC4642C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 06/13/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/11/2024; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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: 53 YR
• Patient Sex: Female