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

Model Number	ONXACE-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In 2016, on-x technologies incorporated (on-x) became a wholly owned subsidiary of cryolife, inc.(cryolife).A retrospective review of the on-x complaint system was performed to identify any areas requiring additional action and to appropriately assimilate the on-x process into the cryolife quality management system.In an abundance of caution this mdr is being reported to satisfy regulatory reporting obligations.The on-x 614 heart valve design fmea 940816 01 rev s thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and instruction for use (ifu).Adverse events potentially associated with the use of prosthetic heart valves include prosthesis leaflet entrapment (impingement) and cardiac arrhythmia.
Event or Problem Description
According to the available information, the patient was implanted with a size 21mm on-x aortic heart valve with conform-x sewing ring and extended holder.The 21mm was too tight and was causing impingement.The patient was placed back on the pump and went into heart block.A size 19mm on-x aortic heart valve with conform-x sewing ring and extended holder was implanted during the same procedure.

• Brand Name: ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• MDR Report Key: 5967521
• Report Number: 1649833-2016-00019
• Device Sequence Number: 1916963
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2016

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
• Operator of Device: Physician
• Device Expiration Date: 02/22/2022
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR