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

Model Number	VAMC3434C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: vamc3434c100tu, sn (b)(4), expiration date: 2018-05-10, udi # (b)(4); vamf3834c150tu, sn (b)(4), expiration date: 2018 -07-18, udi # (b)(4).
Event or Problem Description
A valiant stent graft system was implanted in the patient for the endovascular treatment of a small penetrating ulcer that was approximately 3 cm long and a 7 cm long distal aortic dissection.The celiac artery had been previously coiled on an unknown date prior to the index procedure.The stent grafts were implanted approximately 3 cm proximal to the celiac artery.It was reported that, approximately four months post index procedure, a ct revealed that there was false lumen perfusion and that the dissection had continued to increase.The physician elected to implant an additional valiant stent graft distal extension twenty-three days later.The dissection was successfully covered and the event was resolved.Per the physician, the cause of the event was due to distal aortic remodeling.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: 6247275
• Report Number: 2953200-2017-00044
• Device Sequence Number: 10869284
• Product Code: MIH
• UDI-Device Identifier: 00643169346574
• UDI-Public: 00643169346574
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/28/2016

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: 09/27/2017
• Device Model Number: VAMC3434C150TU
• Device Catalogue Number: VAMC3434C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 78 YR