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

Model Number	VAMF3232C150TU
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2017
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 system was implanted into a patient for the endovascular treatment of a thoracic aortic aneurysm.It was reported that the initial deployment of the valiant stent graft in the transverse thoracic aorta was successful.When the physician turned the handle of delivery catheter to release the suprarenal struts, the tip capture release did not function.The physician disassembled the back of the delivery catheter and was able to release the suprarenal struts.The valiant stent graft was successfully implanted.Per the physician, the cause of the event was related to the device.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the device was returned in an endovascular return kit.The device was returned bloodied with the stent graft not loaded within the delivery system as it was deployed in the patient.Upon inspection of the device, there was a kink approximately 135 mm from the edge of the graft cover.The delivery system was returned disassembled (external slider, capture release handle).There was a break to the backend of the screw gear in the area of the capture release.The rest of the device was unremarkable.Inspection of the capture tubing found transparent/glossy material located approximately 1 cm above the back end t-tube.The transparent/glossy material was about 1 mm in length.The event was confirmed; the difficult to deploy most likely was related to the silicone adhered to the capture tubing not allowing passage through the silicon seal.Previous investigation for silicone sticking to the tip capture lumen has been performed.However, a definitive root cause could not be conclusively determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6964161
• Report Number: 2953200-2017-01601
• Device Sequence Number: 16323295
• Product Code: MIH
• UDI-Device Identifier: 00643169346987
• UDI-Public: 00643169346987
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 12/11/2017

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: 08/21/2019
• Device Model Number: VAMF3232C150TU
• Device Catalogue Number: VAMF3232C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR