BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2980722 · Received February 27, 2013

    Report

    Report Number
    2015691-2013-19402
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    May 1, 2012
    Report Date
    February 1, 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

    AT THE TIME OF THE INDEX PROCEDURE THE PATIENT SUSTAINED VASCULAR AND PROCEDURAL COMPLICATIONS. THESE EVENTS HAVE BEEN INVESTIGATED AND SUBMITTED UNDER REPORT NUMBERS 2015691-2011-16458 AND 2015691-2011-16210. DURING THE PATIENT'S ONE YEAR FOLLOW UP VISIT, REVIEW OF HER NEUROLOGICAL SYSTEM INDICATED POSITIVE FOR SENSORY CHANGE (RIGHT LOWER EXTREMITY UPPER THIGH FEELS NUMB SINCE SURGERY), AND NEGATIVE FOR DIZZINESS, TINGLING, SEIZURES, LOSS OF CONSCIOUSNESS AND HEADACHES. THE PATIENT WAS ALERT AND ORIENTED TO PERSON, PLACE AND TIME, WITH NO CRANIAL NERVE DEFICIT. ECHO IMAGING DURING THE 1-YEAR FOLLOW UP VISIT REVEALED A WELL SEATED SAPIEN VALVE WITH TRIVIAL PVL AND MILD CENTRAL LEAK. THE PATIENT REPORTED A CVA SINCE HER LAST VISIT (OVER THE PAST SIX MONTHS) AND INDICATED THAT SHE WAS SEEN BY A NEUROLOGIST BUT DID NOT HAVE ANY FURTHER INFORMATION AT THAT TIME. THE PATIENT WAS CONTACTED BY THE HOSPITAL STUDY COORDINATOR ON MULTIPLE OCCASIONS REGARDING HER NEUROLOGICAL CONSULTATION FOR THE CVA EVENT; HOWEVER, NO INFORMATION WAS OBTAINED FROM THE PATIENT. PER THE INSTRUCTIONS FOR USE FOR THE EDWARDS SAPIEN VALVE, STROKE, CEREBRAL VASCULAR ACCIDENT (CVA) AND TRANSIENT ISCHEMIC ATTACKS, ARE WELL KNOWN COMPLICATIONS ASSOCIATED WITH THE TRANSCATHETER HEART VALVE PROCEDURE. MAJOR RISK FACTORS FOR CVA AND STROKE INCLUDE HTN, ATRIAL FIBRILLATION, DIABETES, FAMILY HISTORY OF STROKE, HIGH CHOLESTEROL, INCREASING AGE, AND RACE. AT THIS TIME THE EXACT CAUSE FOR THE REPORTED EVENT CANNOT BE CONFIRMED; HOWEVER, THERE ARE MULTIPLE POTENTIAL CAUSES FOR THE REPORTED EVENT, INCLUDING THE PATIENT'S ADVANCED AGE, AORTIC STENOSIS, TIA, ATRIAL FIBRILLATION AND CAD. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION OR LABELING ISSUES, NO FURTHER INVESTIGATIONAL ACTIVITIES CAN BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT 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 PREVENTIVE ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS CASE WILL BE REOPENED AND INVESTIGATED.

    Description of Event or Problem · 1

    AS REPORTED VIA THE DEPARTMENT OF SAFETY, THROUGH THE (B)(4) STUDY, AT THE PATIENT'S 1-YEAR FOLLOW-UP VISIT, THE PATIENT WAS TOLD THAT SHE HAD A STROKE 9 MONTHS S/P TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. HOWEVER, THE PATIENT'S NIH EXAM (STROKE SCORE) WAS PERFORMED BY THE PHYSICIAN AND REVEALED A SCORE OF 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85379 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 59031187

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention