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

Model Number VAMF3636C200TE

Device Problems Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

Product analysis conclusions; conclusion: the reported events could not be confirmed on the pre-implant films provided.Procedural video angiograms showing attempts to position and deploy the device in the vessel were not available for assessment of the event; however, the anatomical characteristics reported to have contributed to the event (vessel tortuosity) was confirmed on the image.One (1) image was received showing the valiant captivia device with the external slider retracted and a number of the stent graft rings exposed.The device is slightly curved with no deformation evident form the image.The reported positioning difficulties was confirmed based on the image review.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.

Event Description

A valiant captivia stent graft ((b)(6)) was intended to be implanted during the endovascular treatment of a type b thoracic aortic dissection.It was reported during the index procedure, the valiant captivia stent was advanced through the right femoral artery under fluoroscopic conditions however it could not be delivered to the planned anchoring area, so was not deployed.An attempt to deploy one section of the stent and adjust the position to reach the intended rivet area was completed but the stent could not be deployed in the body.The handpiece rotated one-third of the stent, but the outer shell did not move inside the body.After the delivery system was removed from the body it was noted that the force was transmitted and the four sections suddenly deployed. the procedure was terminated, and 3 non mdt vascular staplers were used to suture the puncture point of the right femoral artery, and one vascular stapler was used for the left femoral artery.It was said that when the pre-determined landing zone was not reached , it was then decided to cover the subclavian artery and perform a diversion, which is an effective treatment but not the best surgical option.This is why the valiant captiva was attempted to be deployed in a different postilion then to what was first intended.Per the physician the cause of the device¿s delivery issues was anatomy-related due to twisted blood vessels.Anatomy was not the only cause of the deployment issue.No additional clinical sequelae were provided, and the patient will be monitored.

• 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: 18612351
• MDR Text Key: 334140515
• Report Number: 9612164-2024-00521
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAMF3636C200TE
• Device Catalogue Number: VAMF3636C200TE
• Device Lot Number: V31178355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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: 80 YR
• Patient Sex: Female