MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number	ONXACE-23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
Implant recovery card received indicated that (b)(6) male received onxace-23 (sn (b)(4)) on (b)(6) 2014 and required explant on (b)(6) 2016 and subsequent replacement with another onxace-23.
Additional Manufacturer Narrative
Attempts to obtain additional information regarding the reported event were unsuccessful and included phone calls on 10/17/2016, 10/19/2016, and 10/20/2016 as well as a letter on 10/20/2016.Should additional information become available it will be evaluated and the complaint will be reopened.The manufacturing records for the onxace-23, 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.During the investigation no non-conformances or deviations were noted.The onxace-23, sn (b)(4), was implanted (b)(6) 2014 and replaced with another onxace-23 on (b)(6) 2016 by the same surgeon.Information received came from irc and contained no other details.There is no information available to indicate reason for explant and whether or not there is any relationship to the valve.However, reoperation and explant are listed in the instructions for use (ifu) as recognized risks associated with aortic valve replacement.A root cause cannot be determined for the reported event.The on-x 614 heart valve design fmea 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.A root cause for the reported event is unavailable.However, the ifu lists adverse events potentially leading to the reoperation and explant of a prosthetic heart valve.This event does not identify additional hazards or modify the probability and severity of existing hazards.

• Brand Name: ONX AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 6029694
• Report Number: 1649833-2016-00065
• Device Sequence Number: 1079234
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 00851788001464
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2016

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 Expiration Date: 07/19/2017
• Device Model Number: ONXACE-23
• Device Lot Number: 3468414
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 12/13/2016
• 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: Hospitalization; Other
• Patient Age: 53 YR