MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE; HEART-VALVE, MECHANICAL

Model Number UNKNOWN

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and 04/30/2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

As reported in (b)(6), this patient experienced bleeding.This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and 04/30/2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.

Manufacturer Narrative

A review of the available information was performed.The purpose of the study is to assess the rate of occurrence of permanent pacemaker implantation within 14 days of surgery with on-x prosthetic heart valve with anatomic sewing ring when used to replace diseased aortic valves in human subjects through the use of a retrospective registry.The protocol for this study is as follows: this study is multicenter and retrospective.All centers will follow a common protocol in which eligible patients will be entered into the registry after the 14th postoperative day.No procedures will be done and only retrospective data covering the preoperative, operative and the first 2 weeks postop will be collected.The valve safety primary endpoint is "occurrence of permanent pacemaker implantation within 14 days of surgery as a valve-related adverse event per the definitions of the aats/sts guidelines." the valve safety secondary endpoint is "occurrence of other valve-related adverse events within 14 days of surgery per the definitions of the aats/sts guidelines." per the information available to us, this study began in 2013.The study was closed out 04/30/2018 and we are now becoming aware of the primary and secondary endpoints reported by all of the centers.For each event, the date of implant, date of event, and valve-identifying information is unknown.The patient of the recently closed on-x prosthetic heart va lve anatomic suture ring postmarket registry was a 58 year old white male, nyha ii.By protocol, he is the recipient of an onxan or onxane model on-x valve in the aortic position.He had prior cardiac surgery, receiving a pacemaker in 2007.Postoperatively, he did not receive another pacemaker but was reported to have had a cardiac bleeding event.Excessive bleeding was noted as an intraoperative adverse event, so it is not clear from the dataset if this complaint represents a new, postoperative bleeding event or a reiteration of the intraoperative bleeding event.We have no other information available following this observation.The study protocol limits adverse event reporting to 14 days postop.Because the reporting period is within 14 days of the date of surgery, the bleeding event occurs either at surgery, in which case it is not valve related, or less than 14 days postop, in which case it would be classified as an early event and may or may not be valve-related.But as we have no additional information on the timing or nature of the bleed, there is not enough information to say what, if any, relationship this event has to the valve.Nevertheless, the instructions for use lists bleeding as a potential complication of aortic valve replacement (avr) [ifu].The event is described as a cardiac bleed, but we don't know if this is in reference to a surgical event (i.E.Intraoperative) or postoperative.It may be related to the trauma of surgery.Consequently, we do not have enough information to know what, if any, relationship the reported bleed has to the valve.No further action is required at this time without additional information.This report is being submitted as required by 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

As reported in the on-x prosthetic heart valve anatomic suture ring post-market study, this patient experienced a cardiac bleed.This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and 04/30/2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE
• 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: 7550143
• MDR Text Key: 109483172
• Report Number: 1649833-2018-00058
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/30/2018
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 98