MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	305U
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Calcium Deposits/Calcification (1758); Death (1802)
Date of Event	01/13/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.No device involvement in the patient's cause of death has been received.Additional information has been requested, but no new information has been received to date.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information from this patient's daughter, that three years, seven months post implant of this bioprosthetic valve, the patient was having trouble breathing and was referred to have her heart valve replaced due to the valve leaking.During the surgery, the surgeon noted that it looked like there was an infection on the valve and "buildup of calcification and plaque." the patient never recovered from the surgery and passed away the following day.No cause of death or device involvement was reported.
Additional Manufacturer Narrative
Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Based on the limited information received, there was no allegation that the death was related to the valve or its function nor was there any allegation that the valve contributed to the patient's death.Without the return of the valve for analysis, a root cause of the event cannot be determined.However, based on the received information, the reported regurgitation potentially could be caused by the calcification and infection.Calcification has been an inherent risk of surgical valve replacement.Also, this event the occurrence of infection was greater than 12 months post implant (over 3 years).Based on the descriptive comments outlined from the journal literature, complaints which occurred greater than 12 months post implant were largely considered to be community acquired (refer to note 1).Therefore, it was unlikely that the reported infection originally came from the device and/or manufacturing valve process.Note 1 - mylonakis, e., and calderwood, s.B.Infective endocarditis in adults.New england journal of medicine.345 (18).1318-1330.Nov.1, 2001.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6332274
• Report Number: 2025587-2017-00250
• Device Sequence Number: 13855638
• Product Code: LWR
• UDI-Device Identifier: 00613994760661
• UDI-Public: 00613994760661
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2017

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: 02/22/2016
• Device Model Number: 305U
• Device Catalogue Number: 305U219
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided; 04/10/2017
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 04/11/2017; 09/29/2017
• 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
• Patient Age: 70 YR