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

Model Number	VAMF2424C150TU
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
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 captivia stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic transection.It was reported that during the index procedure, when attempting to deploy the proximal barespring, the deployment knob had resistance and would not disengage.Multiple attempts were made at this before deciding to disassemble the handle and manually deploy the barespring.After handle disassembly, the proximal tipcap was deployed and the device was retracted out of the patient.The final angiogram identified no visible damage to the vasculature or the device.The patient had normal distal pulses at the end of the case.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: numerous kinks were observed along the middle member.The distal end of the stent stop was damaged.The handle had been disassembled; the slider/handle, front grip and tip capture release had been removed from the handle.The handle was opened to inspect the t-bar and silicone seal.It was not possible to move the t-bar as the silicone seal had adhered to the peek lumen.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product evaluation summary: numerous kinks were observed along the middle member.The distal end of the stent stop was damaged.The handle had been disassembled; the slider/handle, front grip and tip capture release had been removed from the handle.The handle was opened to inspect the t-bar and silicone seal.It was not possible to move the t-bar as the silicone seal had adhered to the peak lumen.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,ie
• MDR Report Key: 7450034
• Report Number: 2953200-2018-00574
• Device Sequence Number: 19095869
• Product Code: MIH
• UDI-Device Identifier: 00643169347021
• UDI-Public: 00643169347021
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2018

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: 09/27/2019
• Device Model Number: VAMF2424C150TU
• Device Catalogue Number: VAMF2424C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 07/18/2018; 08/08/2018; 10/06/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/03/2018; 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 84