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

Model Number	VAMF4646C200TU
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A valiant captivia stent graft system was implanted in a patient for the endovascular treatment of a 5.3 cm in diameter thoracic aortic aneurysm.It was reported that during the deployment of the valiant stent graft, the physician was turning the blue portion of deployment handle and there was a clicking sound and periodically sticking/catching during rotation.The valiant stent graft was successfully deployed at the intended landing zone.The physician stated that the cause of the event could not be determined.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the complaint could not be confirmed since the event took place in-vivo; the graft cover was successfully retracted and recombined without issue on the bench.No clicking sound or catching was observed during analysis.The root cause of the event could not be conclusively determined; however, the two kinks noted in the region of the stent graft may have led to higher than typical deployment forces, which may have subsequently caused the clicking and catching encounter during the deployment.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.
Additional Manufacturer Narrative
Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6492283
• Report Number: 2953200-2017-00596
• Device Sequence Number: 1268991
• Product Code: MIH
• UDI-Device Identifier: 00643169346512
• UDI-Public: 00643169346512
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: VAMF4646C200TU
• Device Catalogue Number: VAMF4646C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided; 05/01/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 05/24/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR