FDA Adverse Event Injury Summary report: N

SORIN CARBOMEDICS VALVE AORTIC MITROFLOW LXA23

MDR report key: 1840231 · Received September 15, 2010

Report

Report Number
MW5017468
Event Type
Injury
Date Received
September 15, 2010
Date of Event
March 12, 2010
Report Date
September 15, 2010
Manufacturer
SORIN GROUP
Product Code
LWR
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PATIENT UNDERWENT AORTIC VALVE REPLACEMENT AND CAB X2 ON (B)(6) 2010. HE RETURNED TO HOSPITAL WITHIN 2 WEEKS OF HIS DISCHARGE WITH SYNCOPAL EPISODES AND ELEVATED WBCS AND WAS FOUND TO HAVE PROSTHETIC VALVE ENDOCARDITIS WHICH HAD CAUSED A POSSIBLE ABSCESS FORMATION. A TEE WAS PERFORMED WHICH DEMONSTRATED A PROBABLE VEGETATION EXTENDING FROM THE AORTIC ROOT THROUGH THE FISTULA INTO THE RIGHT ATRIUM. FOR THIS REASON, HE WAS PLACED ON ANTIBIOTICS PER INFECTIOUS DISEASE MD'S RECOMMENDATION. THE CARDIAC SURGEON PROCEEDED WITH ALTERNATE PLANS FOR AORTIC VALVE REPLACEMENT AS WELL AS PLACEMENT OF A HOMOGRAFT AND REPAIR OF THE FISTULA. THE PATIENT PROCEEDED WITH SURGERY ON (B)(6) FOR WHICH HE DID HAVE A REDO STERNOTOMY WITH A RIGHT ATRIAL TO LEFT VENTRICULAR FISTULOTOMY AND RECONSTRUCTION OF THE AORTIC ROOT AND THE RIGHT ATRIUM USING A 20-MM HOMOGRAFT AND A BOVINE PERICARDIAL PATCH, PATIENT STAYED FROM (B)(6), UNTIL HIS DISCHARGE ON (B)(6) 2010. PATIENT HAD A SLOW RECOVERY, AND WAS DISCHARGED ON (B)(6) TO A SKILLED NURSING FACILITY. HE WAS READMITTED TO HOSPITAL (B)(6)2010 WITH TACHYCARDIA AND DISCONTINUED (B)(6)2010, CARDIAC ECHO DONE AT THIS TIME SHOWED NORMAL FUNCTION AND NO ENDOCARDITIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SORIN CARBOMEDICS VALVE AORTIC MITROFLOW LXA23 AORTIC PERICARDIAL HEART VALVE PROTHESIS LWR SORIN GROUP 266219

Patients

Seq Age Sex Outcome Treatment
1 68 YR Other| S