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

Model Number	305C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hemolytic Anemia (2279); Blood Loss (2597)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: device remains implanted.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.It was noted on the clinical paperwork that the physician did not feel the bleed was related to the valve.
Event or Problem Description
Medtronic received information that the same day post implant of this aortic bioprosthetic valve, the patient presented with an intrathoracic bleed which required the patient to go back into the operating room for surgical exploration.Exploration of the surgical site noted that the source of the bleed could not be determined.The patient received 3 units of packed red blood cells, 3 units of platelets and 2 units of fresh frozen plasma.Medication was given to the patient and the issue was resolved the following day.The device remains implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that 5 days post implant the patient was suspected to have anemia.No intervention has been performed.5 months and 7 days post implant the anemia has been resolved.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6984451
• Report Number: 2025587-2017-01941
• Device Sequence Number: 13575351
• Product Code: LWR
• UDI-Device Identifier: 00643169594722
• UDI-Public: 00643169594722
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: 305C
• Device Catalogue Number: 305C229
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 10/23/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85