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

Model Number	VAMC4444C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Injury (2348); Pseudoaneurysm (2605)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: vamc4444c200tu, serial/lot #: (b)(4), ubd: (b)(6) 2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant stent graft systems were implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm of 57mm diameter.The patient was noted to have mild/moderate aortic tortuosity.It was reported that approximately 3 weeks later the patient presented with a pseudo aneurysm at the site of the left arm brachial access area and a hematoma in the left am.The event was assessed by the investigator to be procedure related.It was reported the patient was hospitalized on (b)(6) 2018 and an intervention procedure was carried out the next day to repair the left brachial artery aneurysm and remove the hematoma.The event was reported to be resolved with good healing of the incision site and a palpable radial pulse to the left wrist.The patient was discharged two days later.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: 7845234
• Report Number: 2953200-2018-01261
• Device Sequence Number: 1986614
• Product Code: MIH
• UDI-Device Identifier: 00643169346819
• UDI-Public: 00643169346819
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 06/10/2020
• Device Model Number: VAMC4444C150TU
• Device Catalogue Number: VAMC4444C150TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/05/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 97