SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT

MDR report key: 4225529 · Received November 4, 2014

Report

Report Number: 2648612-2014-00050
Event Type: Death
Date Received: November 4, 2014
Date of Event: October 14, 2014
Report Date: October 14, 2014
Manufacturer: ST. JUDE MEDICAL PUERTO RICO, INC.
Product Code: LWQ
PMA / PMN Number: PP810002
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4). THE RESULTS OF THE INVESTIGATION CONCLUDED BOTH LEAFLETS OPENED AND CLOSED COMPLETELY AND WITH EASE WHEN MANIPULATED. A SECTION OF MYOCARDIUM WAS ADHERENT TO THE SEWING CUFF, AND THE BOTTOM RIM OF THE VALVE ORIFICE CONTAINED A CHIP, WHICH MAY HAVE OCCURRED AT EXPLANT. NO SIGNIFICANT CALCIFICATIONS WERE OBSERVED AND GRAM STAIN WAS NEGATIVE FOR ORGANISMS. NO EVIDENCE WAS FOUND TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD AND THE ANALYSIS PERFORMED. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

Description of Event or Problem · 1

AN AORTIC VALVE REPLACEMENT PROCEDURE WAS PERFORMED AND ANOTHER MANUFACTURER'S VALVE WAS IMPLANTED WITH SUBSEQUENT INTRAOPERATIVE COMPLICATIONS. THE VALVE WAS REMOVED AND THIS AORTIC VALVED GRAFT WAS IMPLANTED. AFTER 10+ HOURS ON BYPASS, CROSS CLAMP WAS REMOVED. THE HEART INITIALLY EJECTED IN NORMAL FASHION, THE VALVE LEAFLETS FUNCTIONED NORMALLY, THEN THE LEAFLETS BECAME IMPEDED. IT WAS REPORTED THE LEAFLETS WERE POSSIBLY ENTRAPPED WITH THROMBUS DUE TO EXTENDED PUMP TIME. THE PATIENT EXPIRED ON THE TABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
705463	SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT	AORTIC VALVED GRAFT	LWQ	ST. JUDE MEDICAL PUERTO RICO, INC.	21VAVGJ-515	4292149

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Death\| H\| R