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

Model Number	VAMF3632C150TU
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 65mm diameter thoracic aortic aneurysm.It was reported that during the index procedure, the physician modified the valiant stent graft system and placed it in the abdominal aorta with fenestrations.It was reported that the modified graft could not rotate due to the patient anatomy and was partially deployed in the abdominal aorta under extreme torque.Upon delivery of the stent graft, the top cap released due to torque.The right renal fenestration could not be cannulated.The left renal was cannulated and an atrium stent graft was inserted.The physician placed another manufacturers 35mm stent graft to complete the abdominal portion of the stent graft.The right renal could not cannulate and the fenestration remained open.It was reported that the following day, re-intervention was performed to cannulate the renal.This was unsuccessful and so another attempt was made 3 days later again.The physician did an approach via the arm and groin and eventually placed an atrium covered stent as a snorkel into the right renal from above behind the stent graft.An atrial septal plug was placed in the fenestration from below to plug the hole and the renal snorkel was extended.Per the physician, the cause of the event is due to patient anatomy.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
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: 7850304
• Report Number: 2953200-2018-01272
• Device Sequence Number: 1171464
• Product Code: MIH
• UDI-Device Identifier: 00643169400153
• UDI-Public: 00643169400153
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 11/23/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: VAMF3632C150TU
• Device Catalogue Number: VAMF3632C150TU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 11/23/2018
• 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: 83 YR