MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ON-X PROSTHETIC MITRAL VALVE WITH STANDARD SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXM-27/29

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

Patient Problems Mitral Regurgitation (1964); Regurgitation, Valvular (2335); No Information (3190)

Event Date 12/16/2019

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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to initial reports, returned implant registration card for onxm-31/33 sn (b)(4) implanted (b)(6) 2019 in the mitral position.A search for the patient in device tracking showed an irc for onxm-27/29 sn (b)(4) implanted (b)(6) 2017 in the mitral position.This investigation is relegated to the onxm-27/29 sn (b)(4).

Manufacturer Narrative

The manufacturing records for the onxm-27/29 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-27/29 sn: (b)(6) was implanted in the mitral position of a morbidly obese 40-year-old female patient on (b)(6) 2017.This was a redo operation.The first operation was not identified nor described, unless it refers to placement of an automatic implantable cardioverter defibrillator (aicd).The patient was exhibiting nyha ill symptoms.Transthoracic echo (tte) suggested the possibility of paravalvular leak (pvl).A follow-up transesophageal echo (tee) indicated severe mitral regurgitation through the valve, i.E.Not paravalvular.However, the tee also indicated normal valve leaflet motion and non-obstructed.On reoperation, the surgeon removed pannus (tissue) surrounding the cuff region of the valve, but also noted that it was not impinging upon the leaflets.In brief, a prosthetic valve without any identifiable abnormalities exhibited severe regurgitation.The decision was made to replace this valve on (b)(6) 2019 (2 years and 172 days post-implant).Per the operative report on (b)(6) 2019, car-knot sutures were removed; the valve was explanted and replaced by an onxm-31/33 sn: (b)(6) prosthesis.Furthermore, the report noted that the explanted valve leaflet motion appeared normal.As of on (b)(6) 2020, the patient "looks and feels well." this is a case of prosthetic valve dysfunction, of unconfirmed origin, as it appeared to be functioning normally and the leaflets did not appear to be obstructed.The valve was not returned to the manufacturer for examination so no direct observations could be made.Root cause for this event is prosthetic valve dysfunction of unidentifiable origin.No further action is required.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 MITRAL VALVE WITH STANDARD SEWING RING
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9627624
• MDR Text Key: 176933375
• Report Number: 1649833-2020-00079
• 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
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/10/2020
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR