MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number	ONXANE-19
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/27/2020
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
According to the initial report, onxane-19, serial number (b)(4) was implanted and explanted within the same procedure.
Additional Manufacturer Narrative
On 03/27/2020 an onxane-19, sn (b)(6) was used in a case for a 27-year-old male in the aortic position that saw an additional non-on-x prosthetic valve attempted before finally settling on a third, also non-on-x, prosthetic valve.The outcome of this surgery is unknown.We have little additional information about the on-x valve other than a spreadsheet from the site listing it as ¿explanted¿ and presumed to be discarded on site.It was not returned to the manufacturer.We do not have any information from the site that describes in finer detail the use of the on-x valve.Consequently, we do not have enough information to know what, if any, contribution the valve had to the decision to implant/explant sn (b)(6).The instructions for use for the on-x valve lists the possibility of explantation as a consequence of a complication of prosthetic heart valve replacement [ifu].But in this instance, we do not have any information to help us identify that complication.There is not enough information to determine what, if any, contribution the on-x valve had to the decision for its removal same day of surgery.A risk analysis was performed.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 far as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.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: ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 10013846
• Report Number: 1649833-2020-00013
• Device Sequence Number: 2208686
• Product Code: LWQ
• UDI-Device Identifier: 00851788001648
• UDI-Public: 00851788001648
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: 08/10/2021
• Device Model Number: ONXANE-19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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: Other
• Patient Age: 26 YR