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

Model Number ONXM-31/33

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Heart Problem (4454)

Event Date 09/23/2022

Event Type  Injury  

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 ¿ formerly cryolife/jotec.

Event Description

According to initial reports, an implant registration card (onxm-27/29 sn (b)(4) implant date (b)(6) 2022 was returned from the user facility for a patient with an existing on-x heart valve (onxm-31/33 sn (b)(4)) implant date (b)(6) 2017.This investigation is relegated to onxm-31/33 sn (b)(4).Multiple attempts for additional information have gone unmet.

Manufacturer Narrative

An implant registration card (onxm-27/29 sn (b)(6) was returned from the user facility for a patient with an existing on-x heart valve (onxm-31/33 sn (b)(6).Both ircs notate the valves were implanted in the mitral position suggesting the onxm-31/33 sn (b)(6) was explanted.This investigation is relegated to onxm-31/33 sn (b)(6).Multiple attempts for additional information have gone unmet.The valve was not returned from the user facility to the manufacturer.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.During the investigation no non-conformances or deviations were noted.Change orders for leaflet tuning are performed as a part of the standard manufacturing process.A review of the available information was performed.On (b)(6) 2017 an onxm-31/33 sn (b)(6) was used in a case for a 63-year-old female and implanted in the mitral position.A second mitral on-x was reported to device tracking as implanted in the same position, same patient: (b)(6) 2022, onxm-27/29 sn (b)(6), (1,947 days post implant).Multiple attempts to receive additional information received no response including a letter via fedex to surgeon at (b)(6) hospital on (b)(6) 2022.Review of manufacturing records show no processing issues with the original valve.The valve was not returned to the manufacturer for examination.We have no information about the explanted on-x valve other than the tracking notice and assume the valve was discarded on site.Consequently, we do not have enough information to know what, if any, contribution the valve had to the decision to replace it.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.Root cause for this event is unknown no further action is required without additional information.Based on the available information, a definitive root cause for this event cannot be determined.Additionally, without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.The manufacturing records 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.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion ¿ formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.

• Brand Name: ONX MITRAL STANDARD 31/33
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ARTIVION, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15798241
• MDR Text Key: 303660706
• Report Number: 1649833-2022-00057
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 08517880001303
• UDI-Public: 8517880001303
• 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: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

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
• Device Expiration Date: 02/10/2023
• Device Model Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/17/2022
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female