FDA Adverse Event Injury Summary report: N

ON-X MITRAL PROSTHETIC HEART VALVE

MDR report key: 3960941 · Received June 27, 2014

Report

Report Number: 1649833-2014-00008
Event Type: Injury
Date Received: June 27, 2014
Date of Event: May 16, 2014
Report Date: June 27, 2014
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Product Code: LWQ
PMA / PMN Number: P000037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SF
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS EVALUATED BY THE SURGEON WHO CONFIRMED THAT THE MATERIAL ON THE VALVE BLOCKING THE LEAFLET FUNCTION WAS THROMBUS. PHOTOS WERE PROVIDED. IN ADDITION, FULL OPERATIVE NOTES WERE PROVIDED STATING THE SURGEON'S ANALYSIS OF THE CONDITION. IT WAS DECIDED THAT THESE EVALUATIONS WERE SUFFICIENT AND THE VALVE DID NOT NEED TO BE RETURNED.

Description of Event or Problem · 1

PATIENT WITH ON-X MITRAL VALVE REPLACEMENT (MVR) PRESENTED WITH VALVE THROMBOSIS. PATIENT IS KNOWN TO BE NON-COMPLAINT WITH ANTICOAGULATION THERAPY. RE-OPERATION PERFORMED, RE-DO MVR WITH ANOTHER BILEAFLET MECHANICAL VALVE. INTRA-OPERATIVELY, SURGEON CONFIRMED THROMBUS ON THE MITRAL VALVE. PATIENT RECOVERED FROM THE SURGERY. VALVE THROMBOSIS IS BY DEFINITION IN THE AATS/STS GUIDELINES A VALVE-RELATED EVENT AND IS THEREFORE REPORTABLE. VALVE THROMBOSIS IS AN EXPECTED ADVERSE EVENT, AS DEFINED IN THE OBJECTIVE PERFORMANCE CRITERIA IN FDA HEART VALVE GUIDANCE, AND ISO 5840, AND THIS OCCURRENCE IS WELL-WITHIN EXPECTED RATE. CORRECTION OF THE EVENT REQUIRED RE-OPERATION, CLASSIFIED AS A "SERIOUS INJURY". THEREFORE, IT IS REPORTABLE AS AN MDR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
376900	ON-X MITRAL PROSTHETIC HEART VALVE	MECHANICAL HEART VALVE	LWQ	ON-X LIFE TECHNOLOGIES, INC.	ONXM

Patients

Seq	Age	Sex	Outcome	Treatment
1	12 YR		Required Intervention