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

Model Number	VAMC4238C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported events could not be determined from the returned film report.Films during 2014 implant of the valiant captivia for repair of the distal type i endoleak were not returned, and images during the recent intervention for treatment of the reported type iiib endoleak and aaa were also not available for review.The reported endoleak type and cause could not be determined; this appeared most likely to have been a fabric tear or junctional endoleak.The cause of the reported patient paralysis occurring 2 hours post-procedure also could not be determined.It is possible that patient anatomy and extended stent graft coverage from the lsa to the common iliac arteries may have led to the paralysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 56 mm abdominal aortic aneurysm.A valiant navion stent graft system was also implanted during the procedure for treatment of a thoracic type iiib endoleak.A talent stent graft system was previously implanted in the patient for the endovascular treatment of a thoracic aortic aneurysm and a bypass to the visceral vessels was also reported to have been carried out.A valiant captivia stent graft was also implanted in the patient for treatment of a type ib endoleak.The type iiib endoleak originated from the previously implanted valiant captivia and talent stent graft systems.It was reported the endurant iis system was implanted infrarenally and then the navion valiant system was implanted.It was reported that the procedure went well, however, two hours post-procedure it was reported that the patient was paralyzed.As per the physician, the cause of the paralysis was due to the patient¿s anatomy.It was reported that the csf drain was implanted prior to the procedure but due to the length of the coverage required (from the lsa to common iliac arteries bilaterally), the patient became paralyzed.The cause of the type iiib endoleak is unknown.No additional clinical sequelae were reported and the patient is being monitored.

• 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: 9007379
• Report Number: 9612164-2019-03895
• Device Sequence Number: 2622727
• Product Code: MIH
• UDI-Device Identifier: 00643169346703
• UDI-Public: 00643169346703
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 09/21/2015
• Device Model Number: VAMC4238C150TU
• Device Catalogue Number: VAMC4238C150TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2019
• Initial Report FDA Received Date: 09/12/2019
• 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: 64 YR