MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE

Model Number	305U221
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	07/06/2021
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.Related event: 2025587-2021-02611.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that several hours post implant of this 21mm bioprosthetic aortic valve, the patient developed exsanguinating hemorrhage.The patient was emergently re-opened and placed on cardiopulmonary bypass (cpb) with large volumes of blood emanating from a hole in the inferior surface of the heart corresponding to a hematoma.The left atrium was opened and the aortic valve looked "fundamentally normal" from the outside but the surgeons "knew we had to remove it and replace it." a non-medtronic bioprosthetic aortic valve was then deployed, which helped cover the dissected area, and was deemed acceptable.Transesophageal echocardiogram (tee) showed good valvular function and the bleeding was largely contained, however, the physicians decided to pack the chest open and treat an acquired coagulopathy.The patient was moved to the intensive care unit (icu) in critical condition.No additional adverse patient effects were reported.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12350233
• Report Number: 2025587-2021-02612
• Device Sequence Number: 1232406
• Product Code: DYE
• UDI-Device Identifier: 00643169595002
• UDI-Public: 00643169595002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 07/27/2021
• Device Model Number: 305U221
• Device Catalogue Number: 305U221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/20/2021
• 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; Life Threatening; Required Intervention
• Patient Age: 62 YR