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

Model Number VAMF3030C150TE

Device Problems Premature Activation (1484); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the gap seen during preparation of the device could not be conclusively confirmed as the delivery system was returned partially deployed due to manipulation of the device by the physician.Once the stent graft was fully deployed and the external slider was recombined with the front grip, a 2-3mm gap between the tapered tip and graft cover was observed.The root cause of the event could not be conclusively determined; however, the manipulation of the delivery system by the physician may have contributed to the 2-3mm gap seen after stent graft deployment.

Event Description

A valiant stent graft system was selected for use in the patient for the endovascular treatment of a thoracic aortic lesion.It was reported that, during inspection and preparation, the physician discovered a gap between the tapered tip and the graft cover.There was no abnormality to the original packaging.Prior to use, the stent graft was prematurely deployed while the physician was attempting to close the gap.Per the physician, the cause of the event was due to a poor seal or gap between the tapered tip and the graft cover.The device was replaced with another valiant stent graft and the surgery was completed.No clinical sequelae were reported and the patient is fine.

• Brand Name: VALIANT CAPTIVIA - FF
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5437349
• MDR Text Key: 38768320
• Report Number: 2953200-2016-00271
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2016

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 Expiration Date: 07/02/2017
• Device Model Number: VAMF3030C150TE
• Device Catalogue Number: VAMF3030C150TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2015
• 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: 00057 YR