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

Model Number VAMC4242C200TE

Device Problem Inability to Irrigate (1337)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the complaint was confirmed; there device was leaking during irrigations.Since the delivery system was not returned, the root cause of the event could not be determined; however, the event could be related to the lack of interference fit between silicone seal and peek inner member.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 system was implanted in a patient for the emergent endovascular treatment of a ruptured thoracic aortic aneurysm.It was reported that during the prepping of the valiant stent graft, the physician was unable to flush the delivery system as the side port was leaking.The stent graft was able to be successfully implanted in the patient.Per the physician, the cause of the event was unknown.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6528564
• MDR Text Key: 74065857
• Report Number: 2953200-2017-00700
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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,Followup
• Report Date: 04/02/2017

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: 09/21/2018
• Device Model Number: VAMC4242C200TE
• Device Catalogue Number: VAMC4242C200TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 04/02/2017
• Supplement Dates FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• 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: 76 YR