BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 1240705 · Received November 25, 2008

    Report

    Report Number
    2135147-2008-00128
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 25, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER MUSCULAR VSD OCCLUDER WAS RECEIVED AT AGA MEDICAL IN TWO PIECES, CUT IN HALF ACROSS THE WAIST. THE DEVICE WAS DECONTAMINATED, MEASURED, AND CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND BOTH OF THE DISC PATCHES AND STITCHING WERE PRESENT, PROPERLY PLACED AND SECURE. THE WAIST PATCH AND STITCHING APPEARED FULLY PRESENT ALBEIT CUT IN TWO. NO OTHER DEFECTS WERE OBSERVED. REVIEW OF THE MEDICAL RECORDS AND IMAGING BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS PATIENT HAD MULTIPLE MUSCULAR VENTRICULAR SEPTAL DEFECTS (VSD) THAT UNDERWENT PA BANDING AS INITIAL PALLIATION. SHE WENT BACK TO THE OR FOR DE-BANDING AND CLOSURE OF HER VSDS. TWO DEFECTS IN THE INLET PORTION OF THE SEPTUM WERE SIGNIFICANT ENOUGH, CUMULATIVELY, TO WARRANT CLOSURE. THE REMAINING DEFECTS WERE SMALL IN SIZE AND DEVICE PLACEMENT WOULD NOT HAVE BEEN FEASIBLE. DURING THE FIRST ATTEMPT, THE GUIDEWIRE BECAME DISLODGED AND THE PATIENT DEVELOPED HEART BLOCK WHICH REQUIRED CARDIAC MASSAGE AND EPINEPHRINE. A 6MM AMPLATZER MUSCULAR VSD OCCLUDER WAS IMPLANTED ON THE SECOND ATTEMPT AND THE DEVICE WAS RELEASED. ONLY AFTER RELEASE DID THE PATIENT DEVELOP MILD TO MODERATE MITRAL REGURGITATION (MR). THE DEVICE WAS REMOVED AND PATCH CLOSURE OF THE DEFECT WAS PERFORMED. THE MILD TO MODERATE MR PERSISTED AFTER THE REMOVAL OF THE DEVICE. REVIEW OF THE IMAGING PROVIDED SHOWED THE EVALUATION OF THE DEFECT, MEASUREMENT OF THE VSDS AND DEVICE PLACEMENT THROUGH A 7F SHEATH, AS STATED IN THE CATH LAB REPORT. THE LEFT DISC APPEARED TO TOUCH THE ANTERIOR MITRAL VALVE LEAFLET DURING ITS EXCURSION. WITH SLIGHT MODIFICATION OF THE ECHO ANGLE, MILD RESTRICTION OF MOTION OF THE MITRAL VALVE WAS OBSERVED ALTHOUGH IT WAS NOT OF SIGNIFICANCE. THE PATIENT HAD MILD MR BEFORE THE DEVICE PLACEMENT WAS ATTEMPTED BUT THERE WAS A DEFINITE INCREASE AFTER THE DEVICE WAS PLACED. THE PERSISTENCE OF THE MR AFTER DEVICE REMOVAL SUGGESTED THAT EITHER THERE WAS MILD MITRAL CHORDAL DAMAGE, UNLESS THE MR HAS IMPROVED BY NOW, OR THE MITRAL VALVE WAS INVOLVED WITH THE SURGICAL CLOSURE AS WELL, I.E., SUTURES. THIS, HOWEVER, IS JUST SPECULATION. NEVERTHELESS, IT WAS A GOOD DECISION TO REMOVE THE DEVICE BECAUSE THIS PATIENT WAS AT HIGH RISK OF AV BLOCK WITH THE DEVICE PROCEDURE. THE OCCURRENCE OF TRANSIENT AV BLOCK WITH THE GUIDEWIRE DURING THE FIRST ATTEMPT WAS A STRONG PREDICTOR OF DEVELOPMENT OF AV BLOCK LATER. AGAS MEDICAL CONSULTANT IS AWARE OF ONE SUCH CASE IN THE PAST. BASED ON THE IMAGES PROVIDED, THESE DEFECTS WERE HIGH INLET MUSCULAR VSDS WHICH CARRIED A HIGHER RISK OF AV BLOCK. THE INCREASE IN MR FROM MILD TO MODERATE AFTER DEVICE PLACEMENT WAS MOST LIKELY DUE TO PARTIAL CHORDAL ENTANGLEMENT. THE MILD DAMAGE TO THE MITRAL VALVE CHORDAE IS SPECULATED TO HAVE BEEN DUE TO THE DEVICE OR THE SUTURES FOR PATCH CLOSURE OF THE DEFECT. ACCORDING TO AGAS MEDICAL CONSULTANT, IT WAS AN EXCELLENT DECISION TO REMOVE THE DEVICE.

    Description of Event or Problem · 1

    A PATIENT WITH A SWISS-CHEESE VENTRICULAR SEPTUM WITH ONE MAIN MUSCULAR INLET AND MULTIPLE TINY APICAL FENESTRATIONS WAS ATTEMPTED VIA PERVENTRICULAR APPROACH IN THE OR. THE TEE SHOWED 5MM AND 3.5MM INLET MUSCULAR DEFECTS IN CLOSE PROXIMITY. A 6MM AMPLATZER MUSCULAR VSD OCCLUDER WAS PLACED THROUGH A SHORT SHEATH THROUGH THE RIGHT VENTRICLE FREE WALL ACROSS THE DEFECT AND DEPLOYED. IT INITIALLY APPEARED TO OCCLUDE BOTH DEFECTS WITHOUT RESIDUAL SHUNT OR INTERFERENCE WITH THE MITRAL VALVE APPARATUS. AFTER 10 MINUTES, MODERATE MITRAL VALVE INSUFFICIENCY DEVELOPED NEAR THE LEFT VENTRICLE DISC. THE DEVICE WAS SURGICALLY REMOVED AND THE VSD WAS REPAIRED. THERE WAS NO OBVIOUS ENTRAPMENT OF THE MITRAL APPARATUS BY THE DEVICE AND MILD TO MODERATE MITRAL VALVE REGURGITATION PERSISTED AFTER THE REMOVAL OF THE DEVICE. NO MITRAL VALVE INSUFFICIENCY WAS NOTED PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER MUSCULAR VSD OCCLUDER AMPLATZER MUSCULAR VSD OCCLUDER MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-006 M08H08-15

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Required Intervention