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

Model Number	ONXACE
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Type of reportable event: "serious injury" chosen because this was an expected adverse event that required the patient to endure a re-operation, which is similar to a serious injury for this procedure.The adverse event was discovered after the event and the hospital had disposed of the valve, so could not evaluate it.The device history record was reviewed and the valve was found to have been built per specifications.Presumed disposed of at hospital.
Event or Problem Description
While entering tracking database implant information, a patient was observed to have received a second implant of the same position (aortic).The surgeon's office was contacted and the operative notes were obtained, which explain why the re-do aortic valve replacement (avr) was done.The patient was diagnosed with paravalvular leak (pvl).Patient was re-operated and a new valve onxace-21, s/n (b)(4) was implanted.The valve being explanted had dehisced just right of the right coronary commisure.Intraop transesohpageal echo showed no pvl post valve replacement.Patient transferred to icu having tolerated the re-op well.The reason this is being reported is pvl is defined in the aats/sts guidelines as valve-related and reportable.It is also an expected adverse event, and is listed among the expected adverse events possible for a heart valve patient, in section 5 of the ifu.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TEHCNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• MDR Report Key: 5617499
• Report Number: 1649833-2016-70027
• Device Sequence Number: 199322
• Product Code: DYE
• 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: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2016

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: Lay User/Patient
• Device Expiration Date: 09/21/2017
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2016
• Initial Report FDA Received Date: 04/28/2016
• 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: Required Intervention
• Patient Age: 50 YR