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

Model Number	VAMF2424C100TU
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/10/2017
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 captivia stent graft system was implanted in a patient for the endovascular treatment of a thoracic aortic transection due to a motor vehicle accident.It was reported that the physician unintentionally covered the left subclavian artery.Access was gained through the patient¿s arm and a snorkel was placed.It was noted that a bypass was not an option due to the patient¿s injuries.The final angiogram showed the left subclavian and vertebral artery were filling.The physician stated that the cause of the event was due to the pigtail coming back with partial filling of the subclavian, which led to an inaccurate mark on the screen.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 - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6277811
• Report Number: 2953200-2017-00107
• Device Sequence Number: 10989741
• Product Code: MIH
• UDI-Device Identifier: 00643169347113
• UDI-Public: 00643169347113
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2017

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: 12/13/2017
• Device Model Number: VAMF2424C100TU
• Device Catalogue Number: VAMF2424C100TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 01/25/2017
• 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: 49 YR