EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Report

Report Number: 2015691-2013-19187
Event Type: Death
Date Received: February 4, 2013
Date of Event: January 3, 2013
Report Date: January 7, 2013
Manufacturer: EDWARDS LIFESCIENCES
Product Code: NPT
PMA / PMN Number: P110021
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED VIA THE PATIENT'S MEDICAL RECORDS FROM THE HOSPITAL. AS NOTED IN THE SOURCE DOCUMENTS, THE SAPIEN VALVE WAS POSITIONED AND DEPLOYED SUCCESSFULLY IN THE TAVR PROCEDURE. MILD PVL AND GOOD PLACEMENT OF THE AORTIC VALVE PROSTHESIS WAS CONFIRMED VIA TEE IMAGING. AT THE 1-YEAR FOLLOW-UP, SHE REPORTED INCREASED ENERGY AND NO SYNCOPE. SHE DID HAVE CONTINUED DYSPNEA WITH MODERATE ACTIVITY, WHICH WAS ATTRIBUTED TO KNOWN LUNG DISEASE (PRE-OP PFTS DEMONSTRATED MODERATE RESTRICTION, DECREASED MVV/MEP, SEVERE DIFFUSION DEFECT). AT THE 2-YEAR FOLLOW-UP, LEG SWELLING AND SOB WERE NOTED ON 3/L NASAL O2. AN ECHO SHOWED MODERATE-SEVERE CENTRAL PROSTHETIC REGURGITATION WITH A PEAK AV GRADIENT OF 24MMHG AND SMALL PVL. IT WAS NOTED THAT THE SEVERITY OF THE PROSTHETIC AR HAD INCREASED. A CT OF THE CHEST DONE "PER PE PROTOCOL" SHOWED EXTENSIVE BILATERAL INTERSTITIAL ABNORMALITY WITH NO EVIDENCE OF PULMONARY EMBOLI. A FEW DAYS AFTER THE 2-YEAR FOLLOW-UP, SHE WAS TRANSPORTED BY AMBULANCE TO THE EMERGENCY DEPARTMENT WITH DIFFICULTY BREATHING AND WAS ADMITTED WITH A DIAGNOSIS OF PNEUMONIA, CHF, COPD, PULMONARY EDEMA, AND PLEURAL EFFUSION. IT WAS THE WISH OF HER FAMILY THAT SHE WOULD NOT BE INTUBATED OR RESUSCITATED WITH MEDICATIONS OR ELECTRICITY. TWO DAYS LATER, SHE DIED IN THE HOSPITAL. THE CATEGORICAL CAUSE OF DEATH (COD) DOCUMENTED IN THE CLINICAL STUDY WAS CARDIAC WITH A DEFINITE RELATIONSHIP TO THE DEVICE AND THE OFFICIAL COD ON THE DEATH CERTIFICATE WAS END STAGE HEART DISEASE. PER THE INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES INCLUDE PARAVALVULAR LEAK AND CONGESTIVE HEART FAILURE. CONGESTIVE HEART FAILURE CAN HAVE MULTIPLE ETIOLOGIES AND IS OFTEN DUE TO PROGRESSION OF UNDERLYING DISEASE PROCESSES, INCLUDING UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, CARDIOMYOPATHY, FLUID OVERLOAD, OR VALVULAR DYSFUNCTION. IT SHOULD BE NOTED THAT THIS ELDERLY PATIENT HAD MULTIPLE CO-MORBIDITIES SUCH AS CHF AND A SIGNIFICANT PRE-EXISTING PULMONARY CONDITION THAT COULD HAVE CONTRIBUTED TO HER DEATH. NO DEFICIENCIES IN THE LABELING ARE NOTED. A COMPLAINT HISTORY FOR THESE TYPES OF EVENTS IS 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.

Additional Manufacturer Narrative · 1

DETAILS ON THE CHF EVENT AND THE CAUSE OF DEATH ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROCESS.

Description of Event or Problem · 1

AS REPORTED TO EDWARDS THROUGH THE CLINICAL TRIAL, AT THE 2-YEAR STUDY VISIT POST IMPLANTATION OF A SAPIEN VALVE, ECHO REVEALED MODERATE TO SEVERE CENTRAL PROSTHETIC REGURGITATION. ACCORDING TO THE ECHO REPORT, COMPARED TO THE STUDY APPROXIMATELY ONE YEAR PRIOR, THE SEVERITY OF THE PROSTHETIC REGURGITATION HAD INCREASED. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS SCHEDULED TO FOLLOW-UP IN THE TAVR CLINIC FOR TEE 2-3 WEEKS LATER. TWELVE DAYS LATER THE PATIENT WAS ADMITTED WITH CHF AND FATIGUE. AT THE TIME OF THIS EVENT, THE FAMILY WAS DETERMINING WHETHER TO TRANSFER THE PATIENT TO THE IMPLANTING HOSPITAL OR TO HOSPICE. THE PATIENT EXPIRED 2 DAYS LATER. THE CAUSE OF DEATH IS NOT AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
46257	EDWARDS SAPIEN TRANSCATHETER HEART VALVE	AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED	NPT	EDWARDS LIFESCIENCES	9000TFX23	2730547

Patients

Seq	Age	Sex	Outcome	Treatment
1	85 YR