MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL STANDARD 31/33; HEART-VALVE, MECHANICAL

Model Number ONXM-31/33

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports, patient with existing onxm-31/33 sn (b)(4) implanted in the mitral position (b)(6) 2020 received onxm-31/33 sn (b)(4), (b)(6) 2020 in the mitral position.This investigation is relegated to onxm-31/33 sn (b)(4).

Manufacturer Narrative

According to initial reports, patient with existing onxm-31/33 sn (b)(6) implanted january 10, 2020 received onxm-31/33 sn (b)(6) march 30, 2020.This complaint is relegated to onxm-31/33 sn (b)(6).Multiple attempts at additional information have gone unmet.The user facility will not release any information without patient consent.The manufacturing records for the onxm-31/33 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.A review of the available information was performed.Onxm- 31/33 sn (b)(6) was implanted in the mitral position of a 24-year-old male patient on (b)(6) 2020.However, on (b)(6) 2020 (70-days post-implant) this prosthetic valve was explanted and replaced with onxm 31/33 sn (b)(6).Multiple attempts were made to obtain additional information; however, the user facility noted they will not release any information without the patient's consent.Thus.No other information was provided, including the status of the patient.Therefore, we have no evidence to suggest what, if any, contribution the original valve made to the explantation.The instructions for use [ifu] for the on-x valve acknowledge reoperation and explantation as potential consequences of a complication following prosthetic valve replacement.But we have no evidence of any valvular malfunction.There is no evidence to suggest what.If any, relationship the valve had to its explantation.No further action is required without additional information.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.

Manufacturer Narrative

According to initial reports, patient with existing onxm-31/33 sn (b)(6) implanted (b)(6) 2020 received onxm-31/33 sn (b)(6) march 30, 2020.This complaint is relegated to onxm-31/33 sn (b)(6).Multiple attempts at additional information have gone unmet.The user facility will not release any information without patient consent.The manufacturing records for the onxm-31/33 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.A review of the available information was performed.Onxm- 31/33 sn (b)(6) was implanted in the mitral position of a 24-year-old male patient on (b)(6) 2020.However, on (b)(6) 2020 (70-days post-implant) this prosthetic valve was explanted and replaced with onxm 31/33 sn (b)(6).Multiple attempts were made to obtain additional information; however, the user facility noted they will not release any information without the patient's consent.Thus.No other information was provided, including the status of the patient.Therefore, we have no evidence to suggest what, if any, contribution the original valve made to the explantation.The instructions for use [ifu] for the on-x valve acknowledge reoperation and explantation as potential consequences of a complication following prosthetic valve replacement.But we have no evidence of any valvular malfunction.There is no evidence to suggest what.If any, relationship the valve had to its explantation.No further action is required without additional information.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 MITRAL STANDARD 31/33
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 10009540
• MDR Text Key: 191405058
• Report Number: 1649833-2020-00010
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/08/2020
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR