EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Report

Report Number: 2015691-2013-19823
Event Type: Injury
Date Received: April 16, 2013
Date of Event: February 28, 2013
Report Date: March 25, 2013
Manufacturer: EDWARDS LIFESCIENCES
Product Code: NPT
PMA / PMN Number: P110021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PER THE INSTRUCTIONS FOR USE (IFU), ENDOCARDITIS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH HEART VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. ENDOCARDITIS IS AN INFECTION OF A NATIVE OR PROSTHETIC VALVE AND MAY OCCUR EARLY OR LATE AFTER VALVE REPLACEMENT. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. ACCORDING TO THE (B)(4) MANUAL, MAJOR PREDISPOSING FACTORS TO INFECTIVE ENDOCARDITIS ARE CONGENITAL HEART DEFECTS, RHEUMATIC VALVULAR DISEASE, BICUSPID OR CALCIFIC AORTIC VALVES, MITRAL VALVE PROLAPSE, AND HYPERTROPHIC CARDIOMYOPATHY. PROSTHETIC VALVES ARE A PARTICULAR RISK. PROSTHETIC VALVULAR ENDOCARDITIS DEVELOPS IN TWO TO THREE PERCENT OF PATIENTS WITHIN ONE YEAR AFTER VALVE REPLACEMENT AND IN 0.5 PERCENT THEREAFTER. IT AFFECTS MECHANICAL AND BIOPROSTHETIC VALVES EQUALLY. IN THIS CASE, WITH THE LIMITED INFORMATION AVAILABLE, THE CAUSE FOR THE INFECTION CANNOT BE CONFIRMED. HOWEVER, EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY AT THE TIME OF MANUFACTURE AND THERE IS NO EVIDENCE TO SUGGEST, AND NO ALLEGATION THAT THE INFECTION 12 WEEKS LATER IS RELATED TO THE VALVE. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO INDICATIONS, WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

Description of Event or Problem · 1

THE PATIENT WAS ADMITTED TO THE HOSPITAL 12 WEEKS POST TAVR WITH SHORTNESS OF BREATH, FEVER AND COUGH, AND DIAGNOSED WITH ACUTE DIASTOLIC HEART FAILURE. TTE THE NEXT DAY SHOWED NO HEMODYNAMICALLY SIGNIFICANT STENOSIS, BUT MODERATE AORTIC REGURGITATION WAS PRESENT. THERE WAS CONTINUOUS SYSTOLIC FLOW ADJACENT TO THE PROSTHETIC VALVE IN THE REGION OF THE MEMBRANOUS VENTRICULAR SEPTUM CONSISTENT WITH PARTIALLY RESTRICTIVE VENTRICULAR SEPTAL DEFECT, POSSIBLY DUE EITHER TO DEVICE EROSION OR FISTULA DUE TO ENDOCARDITIS/AORTIC ROOT ABSCESS. MILD PROSTHETIC DEVICE TRANSLATION AND MILD ISOECHOIC REGION ADJACENT PROSTHESIS MAY HAVE REPRESENTED EDEMA OR EARLY ABSCESS. COMPARED TO THE PRIOR TTE 10 DAYS POST TAVR, THE VENTRICULAR SEPTAL DEFECT, MODERATE PROSTHETIC AORTIC REGURGITATION AND RV ENLARGEMENT WERE NEW FINDINGS. PER REPORT, THE STUDY QUALITY WAS FAIR AND TECHNICALLY LIMITED DUE TO POOR APICAL WINDOWS. DURING THIS ADMISSION THE PATIENT WAS SUSPECTED TO HAVE PNEUMONIA AND LIKELY DUE TO ASPIRATION. PRELIMINARY RESULTS OF BLOOD CULTURES WERE SUGGESTIVE OF (B)(6) SPECIES. THE PATIENT WAS ALSO NOTED TO HAVE FEVER AND LEUKOCYTOSIS SECONDARY TO THE PNEUMONIA. SHE WAS DIAGNOSED WITH BACTERIAL ENDOCARDITIS WITH END STAGE CHF AND EXPIRED 4 DAYS LATER

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
163479	EDWARDS SAPIEN TRANSCATHETER HEART VALVE	AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED	NPT	EDWARDS LIFESCIENCES	9000TFX23

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Required Intervention