MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number	ONXMC-25/33
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, "implant of onx mitral valve went fine.When they looked at echo the felt that there was a peri valvular leak.We discussed the unique signature jets of the onx valve but echo and surgeon both agreed that they saw a mild to moderate leak.Surgeon felt that it was not necessary to go in and fix.Pt was closed and surgery was completed.".
Additional Manufacturer Narrative
The rep was asked on 11/22/2016 if a definitive etiology was determined for the presumed paravalvular leak (pvl) or if it was in fact the unique signature jets and if there was a known current status of patient.He replied same day that ¿the anesthesiologist felt confident that it was not signature jet washes but was indeed a mild to moderate pvl.The surgeon agreed but felt that it was not significant enough to worry about.I have no further information on the patient.¿ the manufacturing records for the onxm-27/29, 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.The onxmc-25/33, sn (b)(4), was implanted (b)(6) 2016 in the mitral position.Post-surgery echo revealed mild to moderate pvl but was not considered clinically significant and the patient was closed.Pvl is a known risk of prosthetic valve placement in either aortic or mitral positions listed in the instructions for use (ifu).As this diagnosis was made during surgery, this pvl is the consequence of placement rather than any developed tissue pathology.Palatianos, et al.Reported two early (<30 days) pvl's in an on-x study of 117 patients while mcnicholas, et al.Describe this as a rate of 0.7 in an on-x study of 142 mitral patients.In the present case, both anesthesiologist and surgeon decided the severity was not enough to warrant corrective action.

• Brand Name: ONX MITRAL CONFORM 25/33
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 6001364
• Report Number: 1649833-2016-00062
• Device Sequence Number: 672862
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 00851788001303
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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 Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other