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

Model Number	ONXAE
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/29/2014
Additional Manufacturer Narrative
None of the options apply to this situation.This is being treated as though an adverse event has occurred, and it has not been corrected through a re-operation.The valve has not been returned because it remains implanted in the patient.
Event or Problem Description
Patient contacted on-x by email on (b)(6) 2016, expressing concern that his cardiologist had apparently done a follow-up echo and diagnosed that he had 2 leaks around the newly-implanted valve at 1 week post-op.He stated his surgeon did not agree, and he has sought a second opinion from mayo clinic, on his own initiative.He was concerned because it appeared to him that he might have to undergo a re-operation.The patient was requesting the intervention of onxlti with his medical providers.Onxlti attempted to have the patient authorize release of his medical records associated with the leak diagnosis.The patient appears to be asymptomatic relative to a paravalvular leak (pvl) diagnosis.Onxlti was pursuing the records/echos so that they could be read by an independent medical expert to see if the characteristic leakage jets associated with the pivot washing (an intentional designed-in feature of the on-x valve) were possibly being mistaken for pvl.However, the patient has not been responsive to our requests for approval to release the records.The valve remains implanted.This is being reported because a pvl event may have occurred.Pvl is an expected adverse event, formally defined to be valve-related and reportable per aats/sts guidelines, it is among the objective performance criteria listed in the heart valve standard iso 5840, and it is listed in the ifu among the adverse events possible for a heart valve patient.

• 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: 5596879
• Report Number: 1649833-2016-70023
• Device Sequence Number: 309793
• Product Code: DYE
• UDI-Device Identifier: 00851788001419
• UDI-Public: 00851788001419
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/21/2016

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: Lay User/Patient
• Device Expiration Date: 07/20/2016
• Device Model Number: ONXAE
• Device Catalogue Number: ONXAE-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2016
• Initial Report FDA Received Date: 04/21/2016
• 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: 43 YR