MAUDE Adverse Event Report: CRYOLIFE, INC. ONX AORTIC ANATOMIC EXT 21; HEART-VALVE, MECHANICAL

Model Number	ONXANE-21
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/01/2020
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 report onxane 21 sn: (b)(4) was implanted on (b)(6) 2020.An obituary for the patient was found with date of death as (b)(6) 2020.This investigation is relegated to onxane 21 sn: (b)(4).No additional information forthcoming.
Additional Manufacturer Narrative
The manufacturing records for serial number (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.A clinical/medical review was performed for the available information.Attempts were made to acquire additional information from the hospital.However, per a cryolife representative, information would not be released without family consent.As a consequence, no information was received concerning why the replacement of mitral sn (b)(4) was deemed necessary.Why a double-valve situation presented itself.Nor why the patient succumbed only one day post-surgery.Therefore, we do not have information to indicate, what if any contribution the aortic valve sn (b)(4), had to the death of the patient.Although, there is no evidence of valve involvement.The instructions for use for the on-x valve lists reoperation, explantation, and death as possible outcomes of complications associated with mechanical heart valve replacement [ifu].According to an sts survey covering 2007 through march 2016, a double-valve (avr+mvr) case has about a 9% rate of operative mortality [sts].There is insufficient information to indicate a root cause for the death of this on-x patient.Because the death is only one day post-op, it is likely classified as an operative mortality.Although the unknown, complication necessitating the avr+mvr in the first place may still be a contributing factor.There is no indication, that the death is valve-related.No further action is required without additional information.A risk review of the available information was performed.The review of the device history record found that the valve met all specifications and testing requirements.There were no issues found in the manufacture of the device.The clinical medical report states, the root cause as: "there is insufficient information to indicate a root cause for the death of this on-x patient.Because the death is only one day post-op.It is likely, classified as an operative mortality.Although, the unknown complication necessitating the avr+mvr in the first place may still be a contributing factor.There is no indication, that the death was valve related".The information given provides neither evidence of valve dysfunction, nor any indication of a relationship between the on-x valve and the event.The ifu provides instruction about the potential adverse events associated with the use of prosthetic heart valves, which may lead to death.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.This report is being submitted as required by federal regulations and does not constitute an admission, that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant, and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: ONX AORTIC ANATOMIC EXT 21
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 10201515
• Report Number: 1649833-2020-00020
• Device Sequence Number: 1074139
• Product Code: LWQ
• UDI-Device Identifier: 00851788001655
• UDI-Public: 00851788001655
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: No Information
• Device Expiration Date: 12/19/2024
• Device Model Number: ONXANE-21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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; Life Threatening
• Patient Age: 45 YR