MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	995MS29
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Calcium Deposits/Calcification (1758); Death (1802); Endocarditis (1834); Low Blood Pressure/ Hypotension (1914); Pseudoaneurysm (2605)
Date of Event	07/03/2018
Type of Reportable Event	Death
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 11 years 8 months post implant of this 29 mm aortic bioprosthetic valve it was explanted and replaced with a 29 mm aortic bioprosthetic valve.The patient had endocarditis 9 years post implant, which left them with severe aortic insufficiency and aortic pseudo aneurysm along with calcification of the aortic root and valve.The patients post op hemodynamics required him to be sent to the intensive care unit (icu) with a balloon pump and the chest was left open as the patient was critically ill and not a candidate for extracorporeal membrane oxygenation (ecmo).Ultimately the patient had vasoplegia which is low systemic vascular resistance leading to hypotension and the patient died that day.The physician does not believe the valve contributed to the cause of death.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 7754248
• Report Number: 2025587-2018-02001
• Device Sequence Number: 1703680
• Product Code: LWR
• UDI-Device Identifier: 00721902316197
• UDI-Public: 00721902316197
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P970031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 05/25/2011
• Device Model Number: 995MS29
• Device Catalogue Number: 995MS29
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: Death; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 74