MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	EVOLUTPRO-23-US
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that fifty-nine days following the implant of this transcatheter bioprosthetic valve, a second transcatheter bioprosthetic valve was implanted for an unknown reason.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received that the first valve was unable to be delivered trans-femorally due to underlying iliac disease.The case was aborted because of vessel complications caused by multiple non-medtronic sheath and dilator insertions.A femoral cutdown with stent graft placement via vascular surgery was done.Fifty-nine days later the second transcatheter bioprosthetic valve was successfully implanted via trans aortic approach.No adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7173623
• Report Number: 2025587-2018-00091
• Device Sequence Number: 13682419
• Product Code: NPT
• UDI-Device Identifier: 00643169954434
• UDI-Public: 00643169954434
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• 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): 01/18/2018

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: 04/01/2019
• Device Model Number: EVOLUTPRO-23-US
• Device Catalogue Number: EVOLUTPRO-23-US
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 01/18/2018
• 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: Required Intervention
• Patient Age: 89 YR