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

Model Number	VAMF4646C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/25/2016
Type of Reportable Event	Serious Injury
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 stent graft system was implanted in the patient for the emergent endovascular treatment a ruptured 6 cm in diameter thoracic aortic aneurysm.The patient¿s anatomy was severely diseased.The valiant stent graft was implanted.It was reported that there was no distal thoracic aortic neck seal/landing zone, (due to the large diameter), and the physician stated that there was no other option but to cover the celiac artery, as a life saving measure.The final angiogram revealed that there was collateral circulation and the celiac artery was perfusing without issue.The patient was sent to recovery.The angiogram performed one day post implant showed an unknown focal endoleak 15 mm proximal to the celiac artery and 30 mm proximal from the distal end of the stent graft, however it was thought to be a type ii endoleak at this time.The physician stated that there was good seal proximally and distally and the patient was sent home with no intervention.The physician had another physician from another hospital review the films.The other physician stated in their opinion there was either a type ib endoleak or a type iv endoleak (jetting) and the patient should have an intervention.Five days later the physician had the patient return for a secondary intervention.The physician elected to implant another valiant stent graft 46x46x200 slightly distal to the first valiant stent graft.The final angiogram after the intervention revealed that the unknown endoleak was resolved.Per the physician the exact cause of the event is unknown.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - CW
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6146509
• Report Number: 2953200-2016-02074
• Device Sequence Number: 627032
• Product Code: MIH
• UDI-Device Identifier: 00643169346512
• UDI-Public: 00643169346512
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2016

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: 07/07/2017
• Device Model Number: VAMF4646C200TU
• Device Catalogue Number: VAMF4646C200TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2016
• Supplement Date Received by Manufacturer: 11/27/2016
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 09/27/2017
• 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: Required Intervention
• Patient Age: 86 YR