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

Model Number VAMF3636C200TE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant captivia stent graft was attempted to be implanted in the endovascular treatment of a 32 mm thoracic aortic aneurysm.It was reported that during the index procedure, the main body could not be entered during the operation, and a dissection of the femoral artery occurred.Ballooning was performed and a 8*10 stent was placed outside the iliac stenosis, however the main body still could not be entered.Ballooning was performed again and the incision was raised 4-5cm upward, it still could not be entered.An attempt to double guide wire was used to stretch the artery at the incision, with no success.It was stated that the stenosis on the other side was more visible, and the angiography of the approach showed more distorted than the right side.The physician then decided to abort the procedure.No cause of the event was reported.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Product analysis the device returned with the external slider and tip capture release handle in the home position.Scratches and slight lifting of the graft cover material was observed.There was no further deformation evident to the device.The reported positioning difficulties were confirmed through analysis.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.

Manufacturer Narrative

B:5 additional information received: the cause of the dissection was reportedly due to atherosclerosis.It was confirmed that the dissection was treated and is now resolved.A:4 updated 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 TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10769734
• MDR Text Key: 214104305
• Report Number: 9612164-2020-04185
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2021
• Device Model Number: VAMF3636C200TE
• Device Catalogue Number: VAMF3636C200TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 11/04/2020; 12/10/2020
• Supplement Dates FDA Received: 11/27/2020; 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 65