MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number	ONXM-27/29
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/31/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
According to the irc, patient implanted with onxm-27/29 ((b)(4)) on (b)(6) 2016 and died on (b)(6) 2016.
Additional Manufacturer Narrative
No additional information was provided.Attempts to obtain additional information regarding the reported event were unsuccessful.Should additional information become available it will be evaluated and the complaint will be reopened.The manufacturing records for the onxm-27/29, sn (b)(4), were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.The onxm-27/29, sn (b)(4), was implanted (b)(6) 2016 and the patient died (b)(6) 2016, nine days postoperatively.The death of patient was noted on the irc and no other information was provided.There is inadequate information available to ascertain what relationship, if any, the valve had to the death of the patient. as a root cause is unavailable, the cause of failure can not be identified in design fmea.However, patient death of unknown cause is tracked as part of the heart valve customer feedback complaint analysis.This event does not identify additional hazards or modify the probability and severity of existing hazards.

• Brand Name: ONX MITRAL STANDARD 27/29
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 5986478
• Report Number: 1649833-2016-00059
• Device Sequence Number: 13555185
• Product Code: LWQ
• UDI-Device Identifier: 00851788001280
• UDI-Public: 00851788001280
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2016

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: Physician
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/29/2016
• Supplement Report FDA Received Date: 12/02/2016; 12/02/2016
• 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: 55 YR