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

Model Number	VAMC4646C200TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: v amf4646c200tu, serial/lot #: (b)(4), ubd: 15-aug-2020, udi#: (b)(4); product id: vamc4646c150tu, serial/lot #: (b)(4), ubd: 15-mar-2019, udi#: (b)(4).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 a 80mm diameter thoracic aortic aneurysm.It was reported that during the index procedure (post successful delivery of the stent grafts) when the sheath was being removed the iliac artery ruptured.An open procedure was performed to repair the ruptured iliac artery.Per the physician, the cause of the event was due to patient anatomy; small iliac access.No additional clinical sequelae were reported and the patient is fine.

• 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: 8008278
• Report Number: 2953200-2018-01509
• Device Sequence Number: 13879821
• Product Code: MIH
• UDI-Device Identifier: 00643169346437
• UDI-Public: 00643169346437
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: VAMC4646C200TU
• Device Catalogue Number: VAMC4646C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/26/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 68 YR