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

Model Number	VAMF3636C100TU
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft was implanted in a patient for the endovascular treatment of a 40mm thoracic aortic dissection.It was reported that during the index procedure the proximal stent would not deploy during normal deployment.It was reported the physician was able to dismantle the back handle and deploy the proximal stent manually and the event was reported to be resolved.The cause of the event is unknown.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary; the cause of the inability to deploy the proximal bare spring could not be determined from the limited pre-implant film report returned.Complete ct¿s prior and post-implant were not available, and images during implant were also not provided therefore the reported event could not be assessed.Other than possible anatomical issues due to implanting with the proximal seal location near the patient¿s dissection, analysis of the returned films did not reveal any other anatomical characteristics that could explain the reported event.A device issue cannot be ruled out as a potential cause.However, the delivery system was not available for return and a product investigation could not be performed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8280991
• Report Number: 2953200-2019-00169
• Device Sequence Number: 1685961
• Product Code: MIH
• UDI-Device Identifier: 00643169347052
• UDI-Public: 00643169347052
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 02/06/2020
• Device Model Number: VAMF3636C100TU
• Device Catalogue Number: VAMF3636C100TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR