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

Model Number	VAMC3434C200TU
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
A valiant captivia stent graft system was attempted for use in a patient for the endovascular treatment of a 6.0 cm thoracic aortic aneurysm.It was noted that the patient had previously had another manufacturer¿s thoracic stent graft implanted and had developed an aneurysm at the distal end.It was also noted that the patient had very tortuous anatomy.It was reported that the valiant device was advanced to within the other manufacture¿s graft.As the stent graft was deployed the graft cover and the stent graft moved together.It became difficult for the physician to continue to unscrew the stent graft so the device was removed.When the device was moved distally into a straighter portion of the anatomy, part of the fabric came forward from under the graft cover.A different valiant device was then inserted and was deployed normally which resolved the event.The physician stated that the event was caused by very tortuous anatomy.No additional clinical sequelae were reported and the patient is fine.

• 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: 6854411
• Report Number: 2953200-2017-01417
• Device Sequence Number: 10927522
• Product Code: MIH
• UDI-Device Identifier: 00643169346772
• UDI-Public: 00643169346772
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2017

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: 08/30/2018
• Device Model Number: VAMC3434C200TU
• Device Catalogue Number: VAMC3434C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR