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

Model Number	VAMF4646C200TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Occlusion (1984)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: vamf4036c150tu, serial/lot #: (b)(4), ubd: 24-aug-2018, udi: (b)(4).Product id: vamc4646c200tu, serial/lot #: (b)(4), ubd: 07-sep-2018, udi: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Two valiant captivia stent grafts were implanted in a patient for the endovascular treatment of a thoracic aortic aneurysm.A third valiant captivia stent graft was implanted.It was reported approximately 3 years post the index procedure, a type iiia endoleak was suspected.The patient then coded while en-route for treatment of the endoleak and occlusion of all three valiant captivia stent grafts was reported per the physician.Visualization could not be achieved due to the occlusions, and so it could not be determined which devices had the type iiia endoleak.An attempt was made to treat the occlusions, however this was unsuccessful.The physician was unable to pass a guidewire into the stent grafts due to the occlusions.The cause of the event is undetermined.No additional clinical sequelae were reported, and the patient will be monitored by their physician.

• 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: 8603779
• Report Number: 2953200-2019-00631
• Device Sequence Number: 2372337
• Product Code: MIH
• UDI-Device Identifier: 00643169346512
• UDI-Public: 00643169346512
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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: 05/30/2019
• Device Model Number: VAMF4646C200TU
• Device Catalogue Number: VAMF4646C200TU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 05/13/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 57 YR