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

Model Number	VAMC2424C100TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/14/2017
Type of Reportable Event	Death
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 in a patient for the endovascular treatment of an unknown size thoracic aortic aneurysm.It was reported that the patient presented emergently with abdominal pain.Ct exam showed a type iii endoleak "with probable dislocation of aortic stent." additional stent grafts were placed and the leak was resolved.As per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information : date of death provided.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information was received reported that an angiogram performed after ct confirmed there was a clear separation however the physician was not able to confirm which devices were involved in the separation.The physician also observed that another manufacture's stent had pulled out of the left renal artery and confirmed this was caused by another manufacturers stent.The physician has confirmed that the patient has since expired of unrelated disease recently.Internal film review: the exact cause of the reported type iii endoleak from a stent graft dislocation could not be determined from the non-contrast films provided.The reported detached device could not be confirmed.It is possible that the dislocation may have occurred a long one of the 90 deg acute stent graft bends seen within the descending thoracic.The pre-implant films were not provided, images during implant were not available for review, and the amount of initial component overlap is unknown.It is possible that aneurysmal morphology changes may have contributed to the device dislocation.It could not be determined if this event may have contributed to the patient¿s death.However, per the physician the patient recently expired from an unrelated disease.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: 7005502
• Report Number: 2953200-2017-01707
• Device Sequence Number: 19170534
• Product Code: MIH
• UDI-Device Identifier: 00613994797513
• UDI-Public: 00613994797513
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2014
• Device Model Number: VAMC2424C100TU
• Device Catalogue Number: VAMC2424C100TU
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 10/14/2017
• Supplement Date Received by Manufacturer: 12/01/2017; 01/04/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/19/2017; 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 103