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

Model Number VAMF3030C200TE

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

Valiant captivia stent graft was implanted during the endovascular treatment of a thoracic aortic ulcer.It was reported during the index procedure, after the three most proximal stent rings were deployed and when attempting to quickly deploy the rest of the stent graft past the aortic arch, deployment difficulties were encountered.It was found that the trigger could not be pressed and it was not possible to deploy the stent by pulling back the trigger to engage the quick-release function of the delivery system.The physician resolved the deployment issue by slowly turning the handpiece to deploy the stent graft.During removal of the delivery system, it was not possible to pull the tapered tip back into the graft outer sheath of the delivery system by pressing the trigger to pull back the slide.The device was removed by slowly turning the handpiece.It was reported that the ifu was followed and there was no damage noted to the delivery system or device packaging during unboxing.There was no vessel thrombus, calcification or tortuosity that may have contributed to the resistance problems.Per the physician the cause of the deployment and removal difficulties was not determined.No additional clinical sequelae were provided, and the patient is fine.

Manufacturer Narrative

Film evaluation summary: the reported deployment and removal difficulties events could not be confirmed on the pre-implant report available, therefore, the cause of the event could not be determined.Lack of complete pre-implant cts did not allow for a more thorough assessment of the pre-implant anatomy.Angiogram videos showing the deployment of the device were not available for review.It is possible that the observed anatomical characteristics such as the presence of thrombus and a highly angulated aortic arch may have contributed to the deployment difficulties, but this could not be confirmed.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.

• 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: 18824604
• MDR Text Key: 337020372
• Report Number: 9612164-2024-01045
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAMF3030C200TE
• Device Catalogue Number: VAMF3030C200TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2023
• 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: 63 YR
• Patient Sex: Male