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-19

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Information (3190)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to initial reports, an onxace-19 sn (b)(4) with a frayed cuff reported.Additional information received: the damage to the valve was observed before cutting the sutures.The valve was implanted using single ethibond excel sutures.The valve was placed in supra annular position by 13 single non-absorbable ethibond -excel, 2-0, sutures with ptfe (polytetrafluorethylene) felt pledgets.Each suture was bounded with 6 surgical knots.The same size valve was used to replace the initial on-x valve.Patient was discharged from the hospital 10 days after surgery in good cardio-pulmonary condition with normally functioning implanted valve.

Manufacturer Narrative

Correction: the event was for damage to the housing, not fraying of the sewing cuff.The manufacturing records for the onxace-19 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.During the investigation no non-conformances or deviations were noted.A sample review was performed 05/18/2018 for the onxace-19 sn (b)(4), by sem microscopy and visual evaluation.A large chip was observed on the valve housing outflow side.Valve was disassembled from sewing cuff and sem microscopy was performed.Energy-dispersive x-ray spectroscopy (eds) analysis found artifacts of iron and chromium within the damaged area.The detected elements of iron and chromium are typically found in surgical instruments (stainless steel) which may indicated the damage was caused by contact with a stainless steel object.Evidence from the sample evaluation suggests the damage occurred by contact with stainless steel object most likely during implantation, iatrogenic.No further action required.The on-x ifu provides detailed precaution and cautionary statements regarding potential damage to the valve during implantation.See the following excerpts from the on-x ifu, 010122 77, rev.C.4.2 - handle the prosthesis with only on-x life technologies, inc.(on-xltl) on-x prosthetic heart valve instruments.Only on- xltl on-x prosthetic heart valve sizers should be used during the selection of the valve size; other sizers may result in improper valve selection.Avoid contacting the carbon surfaces of the valve with gloved fingers or any metallic or abrasive instruments as they may cause damage to the valve surface not seen with the unaided eye that may lead to accelerated valve structural dysfunction, leaflet escape, or serve as a nidus for thrombus formation.Avoid damaging the prosthesis through the application of excessive force to the valve orifice or leaflets.9.3 handling and preparation instructions caution: handle the prosthesis with only on-xltl.On-x prosthetic heart valve instruments.Only on- xltl on-x prosthetic heart valve sizers should be used during the selection of the valve size; other sizers may result in improper valve selection.Caution: avoid contacting the carbon surfaces of the valve with gloved fingers or any metallic or abrasive instruments as they may cause damage to the valve surface not seen with the unaided eye that may lead to accelerated valve structural dysfunction, leaflet escape, or serve as a nidus for thrombus formation.Caution: avoid damaging the prosthesis through the application of excessive force to the valve orifice or leaf lets.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, an onxace-19 sn (b)(4) with a frayed cuff reported.Additional information received: the damage to the valve was observed before cutting the sutures.The valve was implanted using single ethibond excel sutures.The valve was placed in supraanular position by 13 single non-absorbable ethibond -excel, 2-0, sutures with ptfe (polytetrafluorethylene) felt pledgets.Each suture was bounded with 6 surgical knots.The same size valve was used to replace the initial on-x valve.Patient was discharged from the hospital 10 days after surgery in good cardiopulmonary.Condition with normally functioning implanted valve.

• 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: 7395186
• MDR Text Key: 104570999
• Report Number: 1649833-2018-00015
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ONXACE-19
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/09/2018
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other