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

Model Number ONXACE-19

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Insufficient Information (4580)

Event Type  Death  

Event Description

According to the initial report received on 7/7/2022, artivion customer service received a call from [patient] stating she is at the hospital and was told she has a faulty on-x valve implanted on (b)(6) 2020.

Manufacturer Narrative

The manufacturing records for onxace-19, sn (b)(6) 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.On 7july2022 artivion customer service representative reported "i received a call from [patient] early this morning and she is at the hospital and was told she has a faulty onxace-19 implanted on (b)(6) 2020 at [hospital] by [surgeon].She would like a call back at your earliest convenience." multiple attempts were made to contact both the patient and surgeon with no response.We have no way to determine, with the available information, if the complaint of a ¿faulty valve¿ is related to the valve¿s performance or is an accurate relay of information from the surgeon.With further research it was determined that the valve under investigation is onxace-19 sn (b)(6) implanted on (b)(6) 2020.During the course of the investigation it was discovered that this patient was enrolled in the (b)(6) study and was hospitalized with a cva [cerebral vascular accident] on (b)(6) 2022.It was determined that this event [hospitalization for cva] was related to the study drug and will therefore be handled by the clinical and regulatory departments and reported in the ide annual report.The artivion sales representative also reported that this patient passed away.An obituary was found listing a date of death of (b)(6) 2022.We do not have any additional information to indicate what, if any, contribution the valve had to the death of the patient.The valve was not returned to artivion, but the manufacturing records for this serial number document an acceptable product.Although there is no evidence of valve involvement, the instructions for use for the on-x valve lists death as a possible complication of mechanical heart valve replacement [ifu].There is insufficient information to indicate a root cause for the death of this on-x recipient or to determine if the complaint of a ¿faulty valve¿ was in any way related to the valve¿s performance.The risk management and usability engineering file for the on-x heart valve was reviewed.There is insufficient information to indicate a root cause for the death of this on-x recipient or to determine if the complaint of a ¿faulty valve¿ was in any way related to the valve¿s performance.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible and residual risk is acceptable.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 artivion- formerly cryolife/jotec is accurate or has been confirmed by artivion.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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 artivion- formerly cryolife/jotec is accurate or has been confirmed by artivion.

Event Description

According to the initial report received on 7/7/2022, artivion customer service received a call from [patient] stating she is at the hospital and was told she has a faulty on-x valve implanted on (b)(6) 2020.Additional information was received stating this patient is deceased.

Manufacturer Narrative

Additional information was received from the surgeon's assistant.The patient¿s cause of death was an intracerebral bleed from over anticoagulation.This patient was part of the (b)(6) study and experienced a thromboembolic stroke from being on [drug].Patient was transitioned from [drug 1] to [drug 2] which caused the over anticoagulation that resulted in the brain bleed.Per the assistant ¿she did not have a faulty valve.¿ in this case the cause of death is linked to the (b)(6) study drug and not directly to the on-x valve and as such will be handled through the clinical and regulatory departments and reported in the next ide annual report.Per the surgeon's assistant, ¿she did not have a faulty valve;¿ as such the patient¿s claim of being told she had a faulty valve implanted cannot be substantiated.As this patient was treated as part of an investigational study, we have determined that the events in this report were inadvertently reported as commercial events.The event is related to the study drug; therefore, there is no allegation of the event being device related.The risk management and usability engineering file for the on-x heart valve was reviewed.There is no allegation of the event being device related since the event is related to the study drug; thus, severity and occurrence is not evaluated.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible and residual risk is acceptable.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 artivion- formerly cryolife/jotec is accurate or has been confirmed by artivion.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15138000
• MDR Text Key: 296952341
• Report Number: 1649833-2022-00043
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001440
• UDI-Public: 851788001440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXACE-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 51 YR
• Patient Sex: Female