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

Model Number	VAMF3430C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Myocardial Infarction (1969); Paralysis (1997)
Date of Event	03/03/2017
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 stent graft system was implanted for the endovascular treatment of 300 mm in length thoracic dissection.It was reported that the patient had post-operative issues.It was reported that four days post index procedure the patient had coded and was resuscitated and has been having heart problems, maintaining their heart rate and cardiac output.Two or three days later the patient had paralysis in their legs and feet.The physician believes that when the patient¿s heart was unstable, the cardiac output dropped, which infarcted the spinal cord, resulting in the paralysis.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Event or Problem Description
Additional information received reported that the physician stated that the cause of the post-operative complications could not be determined.It was also noted that they were not related to the perforation of the left common iliac artery during the index procedure.
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: 6421639
• Report Number: 2953200-2017-00435
• Device Sequence Number: 1102858
• Product Code: MIH
• UDI-Device Identifier: 00643169400146
• UDI-Public: 00643169400146
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 04/25/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2019
• Device Model Number: VAMF3430C150TU
• Device Catalogue Number: VAMF3430C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided; 04/25/2017
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 05/09/2017; 10/02/2017
• 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: Life Threatening
• Patient Age: 63 YR
• Patient Weight: 60