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

Model Number ONXACE-21

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complete Heart Block (2627)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient of the (b)(6) registry developed complete heart block postoperatively.Permanent pacemaker implanted on day 7.

Event Description

Patient of the mcri on-x low dose post-market registry developed complete heart block postoperatively.Permanent pacemaker implanted on day 7.

Manufacturer Narrative

The manufacturing records for the on-x aortic conform ext 21, onxace-21, sn (b)(4).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.Onxace-21 sn (b)(4).Was implanted (b)(6) 2018 in the aortic position of a 60 year old male participating as patient (b)(6) in the on-x aortic post approval study from which this notice was obtained.A complication report was filed per study requirements indicating that the patient had developed complete heart block [chb] postoperatively, but on the same day of surgery.This was remediated seven days later (b)(6) 2018) with the implantation of a permanent pacemaker.As this was part of a clinical study, the event was reviewed by an expert panel who concluded that the chb was a consequence of the technical aspects of the [surgical] procedure and not due to a defect in the valve.However, per the akins criteria for reporting morbidity and mortality after cardiac valve interventions [akins 2008], the need for a new permanent pacemaker or defibrillator within 14 days after valve intervention is considered a major adverse valve-related event.Still, it should be noted that this classification does not necessarily blame the valve for any malfunction, but rather that the surgical intervention in placing the valve disrupts the anatomy in the vicinity of the valve through which the normal conduction pathway passes.The instructions for use (ifu) list cardiac arrhythmia as a potential adverse event that could lead to reoperation.It also lists prosthesis nonstructural dysfunction which would correspond with the akin classification of a pacer implantation within 14 days post-implant as being valve-related.But there is no evidence that the on-x valve itself failed to perform as designed and expected.This event does not identify additional hazards or modify the probability and severity of existing hazards.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: AORTIC HEART VALVE WITH CONFORM-X 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
• MDR Report Key: 8339366
• MDR Text Key: 136140532
• Report Number: 1649833-2019-00007
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

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 Operator: Health Professional
• Device Expiration Date: 05/23/2024
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/17/2019
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 60 YR