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

Model Number VAMF4040C200TE

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

Film evaluation summary: the reported deployment difficulties could not be confirmed from the limited films available, therefore, the cause of the event could not be determined.Angiograms showing the deployment attempts and the exact moment when the first two stents were deployed and moved from its location where not provided for a thorough review of the reported event.It is possible that the in-vitro fenestration modification performed prior to implant may have contributed to the reported events.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 Description

A valiant captivia stent graft (vamf4040c200te) was implanted during the endovascular treatment of a 63mm thoracic aortic aneurysm.It was noted that before the stent graft was deployed in the patient, the stent graft was pre-opened outside the patient's body where a fenestration technique was used to prepare the stent.It was reported during the index procedure, during deployment, the stent graft slid due to the impact of blood flow and could not reach its intended anchoring position.After the stent graft reached the landing zone, the first two stents were deployed, then the stent graft moved down due to blood flow shock.The proximal end of the stent could not be re-delivered to the anchoring position.The steps of the deployment were followed per the ifu.It is unknown if any vessel thrombus/calcification/ tortuosity may have contributed to the issue.A non mdt stent graft was re-implanted.Per the physician the cause of the deployment issue was not determined.No additional clinical sequelae were provided, and the patient is fine.

• Brand Name: VALIANT CAPTIVIA - FF
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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: 18970259
• MDR Text Key: 338505736
• Report Number: 9612164-2024-01439
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAMF4040C200TE
• Device Catalogue Number: VAMF4040C200TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Date Device Manufactured: 10/18/2023
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 83 KG