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-23

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 03/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An onxace-23 was implanted on (b)(6) 2019.There was an aorto-ventricular disruption and the valve had to be explanted and replaced.

Event Description

An onxace-23 was implanted on (b)(6) 2019.There was an aorto-ventricular disruption and the valve had to be explanted and replaced.

Manufacturer Narrative

Corrections: b1- deselected adverse event.B2- outcomes- deselected all.D10- device available for evaluation- updated to n/a; device returned to manufacturer- updated to yes, date (b)(6) 2019.Preliminary information given to field assurance from the distributor on (b)(6) 2019 stated that onxace-23, serial number (b)(4) was implanted on (b)(6) 2019 and ¿later the surgeon found an aorto-ventricular disruption and had to explant it.¿ based on this information and the late notice to the field assurance department, initial reporting was completed without additional information.According to information received on 06/04/2019, onxace-23, serial number (b)(4)was implanted and explanted on (b)(6) 2019.The operating surgeon, ¿initially on-x aortic valve 23mm, serial number (b)(4) was implanted.There was an aorto-ventricular disruption and the valve had to be explanted and replaced with onx aortic valve 19mm.¿ the surgeon also stated that the patient impact was ¿prolonged surgery¿ and answered ¿no¿ to the question asking, ¿was the product/tissue used/implanted?¿ based on the given information the valve was replaced with a different sized valve within the same operation.Per fda code of federal regulations title 21, part 820.3 (b) a complaint is ¿any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.¿ based on the information provided to cryolife, there is no allegation of deficiency or resultant adverse event caused by cryolife product; therefore, further investigation is not warranted.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 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
• MDR Report Key: 8672044
• MDR Text Key: 147101445
• Report Number: 1649833-2019-00033
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/17/2019
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 64 YR