FDA Adverse Event Death Summary report: N

ON X AORTIC PROSTHETIC HEART VALVE

MDR report key: 5001651 · Received August 11, 2015

Report

Report Number: 1649833-2015-00014
Event Type: Death
Date Received: August 11, 2015
Date of Event: December 31, 2013
Report Date: August 6, 2015
Manufacturer: ON-X LIFE TECHNOLOGIES, INC.
Product Code: LWQ
PMA / PMN Number: P000037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CLINICAL CENTER STATED THIS EVENT IS NOT VALVE-RELATED, WAS CLASSIFIED AS "OTHER-CARDIOVASCULAR". HOWEVER, THE AATS/STS GUIDELINES DEFINES SUDDEN UNEXPLAINED DEATH AS A VALVE-RELATED MORTALITY AND IS REPORTABLE. THEREFORE, THIS IS BEING REPORTED. VALVE NOT EXPLANTED AND NO AUTOPSY.

Description of Event or Problem · 1

EVENT OCCURRED IN (B)(6). OVERALL, PATIENT DISEASE ETIOLOGY WAS ISCHEMIC HEART DISEASE. PATIENT CLASSIFIED AS AVR HIGH RISK. SUDDEN DEATH ON (B)(6) 2013, POST-OPERATIVE - LATE. INR ON DATE OF EVENT WAS 1.6, NYHA CLASS I, CARDIAC CONDITION WAS SINUS RHYTHM. NO AUTOPSY, VALVE NOT EXPLANTED. ON (B)(6) 2015, ONXLTI RECEIVED A SET OF DATA FROM THE SPONSOR OF A (B)(6) POST-MARKET STUDY, WHERE-IN THEY WANTED ON-X TO DO DATA ANALYSIS ON A SET OF DATA CONTAINING ADVERSE EVENTS. THE VALVE ON THIS MDR IS ONE OF THE AE'S. (B)(6). THERE ARE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN THESE RATES AND THIS TRIAL WAS RUN AT INR OF 1.5 TO 2.5 VERSUS THE PMA AT 2.0 TO 3.0. AT LOWER INR LO RATES ARE EXPECTED BASED ON OUR RESEARCH. SO THESE EVENTS WHILE MDR REPORTABLE AS INDIVIDUAL OCCURRENCES, THEY ARE OVERALL IN THE RANGE EXPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
526038	ON X AORTIC PROSTHETIC HEART VALVE	MECHANICAL HEART VALVE	LWQ	ON-X LIFE TECHNOLOGIES, INC.	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Death