BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA INTRODUCER SHEATH SET

    MDR report key: 3040349 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19756
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TAVR PROCEDURE INCLUDE CATHETER SITE BLEEDING WHICH MAY REQUIRE INTERVENTION AND CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES. UPON REVIEW OF PRIOR EVENTS, THE MAJORITY OF APICAL BLEEDING COMPLICATIONS/VENTRICULAR RUPTURES APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. ADDITIONALLY, ACCORDING TO LITERATURE REVIEW, THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. FURTHERMORE, THE LITERATURE ALSO REPORTS THAT FRIABLE TISSUE MAY PREDISPOSE THIS PATIENT POPULATION TO THE DEVELOPMENT OF APICAL ACCESS SITE COMPLICATIONS [REFERENCE: "APICAL-ACCESS-RELATED COMPLICATIONS ASSOCIATED WITH TRANS-CATHETER AORTIC VALVE IMPLANTATION", EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY VOL. 40 2011, PAGES 469-474]. IN THIS CASE, THE ROOT CAUSE FOR THE REPORTED POST-OPERATIVE BLEEDING IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT DURING THE ACCESS SITE CLOSURE THE PATIENT REQUIRED ADDITIONAL SUTURES DUE TO A MINOR BLEEDING. IT IS POSSIBLE THAT THE PATIENT'S ADVANCED AGE ((B)(6)) IN COMBINATION WITH SOME PROCEDURAL FACTORS (E.G. ANTI-COAGULANT MEDICATIONS) CONTRIBUTED TO THE EVENT. NO MALFUNCTION OF THE EDWARDS DEVICE IS ALLEGED. THE IFU 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. 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

    AS REPORTED TO THE EDWARDS LIFESCIENCES CLINICAL SPECIALIST, THE PATIENT WAS TAKEN BACK TO THE OR FOR APICAL BLEEDING AND REPAIR 2 HOURS AFTER TRANSAPICAL TAVR PROCEDURE. CASE SUMMARY: BASELINE BLOOD PRESSURE WAS 93/40MMHG WITH A HEART RATE OF 50 BPM. ACCESS WAS OBTAINED; AFTER PURSE STRINGS WENT IN PRIOR TO THE INSERTION OF THE ASCENDRA SHEATH THE PATIENT WAS NOTICED TO HAVE ST ELEVATION FOR 4-5 MINUTES; THIS RESOLVED AFTER PACING FOR THE BAV. CORONARY ANGIOGRAPHY SHOWED THE CORONARIES WERE PATENT AND UNCHANGED. THE SHEATH WAS INSERTED WITHOUT ISSUES. AFTER BAV THE 23MM SAPIEN VALVE WAS INSERTED AND DEPLOYED IN A FINAL POSITION OF 60:40 AORTIC. ECHO REVEALED MODERATE PERIVALVULAR LEAK (PVL). POST DILATATION WAS PERFORMED WITH 1.5 ML OF ADDITIONAL VOLUME, AFTER WHICH ECHO REVEALED MILD PVL AND NO CENTRAL LEAK. THE PATIENT REMAINED STABLE THROUGHOUT. THE SHEATH WAS REMOVED AND THE SURGICAL INCISION WAS CLOSED. THERE WAS MILD ACCESS SITE BLEEDING DURING THE SURGICAL CLOSURE AND SUTURES WERE PLACED TO REPAIR THE BLEED; CHEST TUBE IN PLACE. THE PATIENT WAS TRANSPORTED TO RECOVERY IN STABLE CONDITION. FINAL BLOOD PRESSURE WAS 83/42. TWO HOURS POST PROCEDURE, THE PATIENT BECAME HYPERTENSIVE AND UNSTABLE. THE CHEST TUBE WAS PUTTING OUT EXCESSIVE BLOOD VOLUME. THE PATIENT WAS TAKEN BACK TO OR, RE-INTUBATED AND THE APICAL BLEEDING WAS REPAIRED. THE PATIENT WAS TAKEN TO ICU AND PLACED ON VENTILATOR. 2 WEEKS LATER THE PATIENT WAS REMOVED FROM THE VENTILATOR FOR "COMFORT CARE"; SHE EXPIRED ON THE SAME DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143894 ASCENDRA INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100IS 59402272

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death