MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION THV 1000-23 3F AORTIC BIO 23MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	1000-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 7 years and 1 month post implant of this aortic bioprosthetic valve, aortic insufficiency was discovered during a coronary catheterization procedure.The patient was brought into the operating room immediately for a transcatheter valve-in-valve implant.While situating the patient on the operating table, systolic blood pressure was reported in the 50s, and cardiopulmonary resuscitation (cpr) was administered to stabilize the patient until the transcatheter valve was deployed.No additional adverse patient effects were reported. .

• Brand Name: THV 1000-23 3F AORTIC BIO 23MM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7609969
• Report Number: 2025587-2018-01518
• Device Sequence Number: 1555207
• Product Code: LWR
• UDI-Device Identifier: 00613994868237
• UDI-Public: 00613994868237
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P060025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: 06/23/2015
• Device Model Number: 1000-23
• Device Catalogue Number: 1000-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/18/2018
• 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: 73 YR