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

Model Number ONXM-31/33

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 01/14/2020

Event Type  Death  

Manufacturer Narrative

A review of the available information was performed.Onxm-31/33 sn (b)(4) was implanted in the mitral position of a (b)(6)-year-old female patient.Date of surgery was (b)(6) 2019.Transesophageal echo (tee) at that time indicated a mean pressure gradient of 3mmhg, no insufficiency, and no leak.On (b)(6) 2020 (222 days post-implant), the patient was exercising, felt poorly, and reported to the emergency room.Echocardiogram indicated one of the two valve leaflets was not present.Re-operation attempted to replace the on-x valve with a tissue valve.Patient suffered cardiogenic shock and metabolic acidosis, developed prolonged hypertension, hypo-perfusion, followed by multiorgan failure before expiring.Date of death was not specified but likely occurred on or near the date of the reoperation.A photograph of the explanted mechanical valve shows a missing leaflet, but no other obvious irregularities.Radiographic scans of the patient show a large dislodged section of valve leaflet apparently wedged within the abdominal aorta at about the level of the l2 vertebra.The imaged leaflet was not available for inspection, but limited records seem to suggest it was not extracted from the patient.Furthermore, close inspection of the radiographic imaged leaflet clearly shows a significant portion of the dislodged leaflet is not visualized, indicating a fractured component.The location of the non-visualized portion of leaflet is not known, however, it is recognized as a section of the leaflet that normally helps keep the leaflet engaged with the valve housing.Cryolife has reviewed the manufacturing records and it was confirmed that all dimensional and performance specifications were met.Multiple requests have been made to the hospital to obtain additional information and for return of the explanted valve, or portions of the explanted valve, for further evaluation.To date the hospital has stated they will not be providing further information including operative notes, other medical records, autopsy findings, or return the explanted valve, or its components, for review.Additionally, the hospital will not allow review on-site by cryolife personnel under supervision.Consequently, the potential cause of the fracture is presently undetermined.Should additional information become available it will be evaluated.Based upon review of the limited information, this appears to be a case of structural valve dysfunction, namely a broken leaflet, of undetermined etiology.The instructions for use [ifu] list prosthesis structural dysfunction as a potential complication of prosthetic valve implantation with the possibility of explantation, reoperation, and/or death.

Event Description

According to the initial report, the patient was implanted with onxm-31/33 in the mitral position on (b)(6) 2019.On (b)(6) 2020 an echocardiogram showed a leaflet was missing and had migrated.This resulted in cardiogenic shock and metabolic acidosis.The surgeon attempted mitral valve replacement, but was unsuccessful.The patient developed prolonged hypertension and hypo perfusion, followed by multi-organ failure.The patient did not live.Radiographic scans show the dislodged valve at the level of the l2 vertebra.Reference medwatch report mw5092348.

• Brand Name: ON-X PROSTHETIC MITRAL VALVE WITH STANDARD SEWING RING
• 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.; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 9694503
• MDR Text Key: 178596409
• Report Number: 1649833-2020-00089
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001297
• UDI-Public: 00851788001297
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/14/2020
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Death; Hospitalization
• Patient Age: 50 YR