BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA¿

    MDR report key: 2881894 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08127
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE INNOVA DEVICE WAS RECEIVED WITH THE GUIDEWIRE LODGED INSIDE THE WIRE LUMEN OF THE DEVICE. THE HANDLE WAS CLOSED AND THE RACK WAS EXTENDED BACK AND LOCKED UP IN BOTH DIRECTIONS. THE DEVICE WAS DISASSEMBLED TO MEASURE AND INSPECT THE SHAFT AND INDIVIDUAL COMPONENTS. THE PROXIMAL INNER AND GUIDEWIRE WERE BENT 70MM FROM THE BASE CLIP. THE OUTER SHAFT WAS BUCKLED AND SHOWED SIGNS OF COMPRESSION NEAR THE NOSE CONE OF THE HANDLE, LIKELY DUE TO THE RECOVERY EFFORT OF RETRACTING THE PARTIALLY DEPLOYED DEVICE. THERE WAS A KINK WITHIN THE RACK ALIGNED WITH THE THUMBWHEEL. THE FIRST RACK TOOTH WAS DEFORMED NEAR THE RETAINER WHICH INDICATES THE RACK WAS TWISTED AT THE TIME OF DISENGAGEMENT WITH THE THUMBWHEEL. SHAFT DIMENSIONS WERE MEASURED, WITH ALL MEETING PRINT SPECIFICATIONS. OTHER COMPONENTS THAT WERE VISUALLY INSPECTED WERE FOUND TO BE ACCEPTABLE. THE INNER CLIP WAS FULLY LOCKED AS RECEIVED NOT ALLOWING THE RACK TO TWIST. THERE WAS BLUE DISCOLORATIONS FROM THE RACK WITHIN THE HANDLE, MIDDLE AND PROXIMAL SECTIONS AND LIKELY DUE TO THE RECOVERY EFFORT OF TRYING TO RELEASE THE STENT WITH REPEATED FORCEFUL MANIPULATIONS OF THE HANDLE. SILICONE COATING WAS EVALUATED USING INDUCTIVELY COUPLED PLASMA MASS SPECTROMETRY (ICP) TO DETECT THE PRESENT OF SILICONE. THE ICP RESULTS DEMONSTRATED THE PRESENCE OF SILICONE IN THE MIDDLE SHAFT CONFIRMING SILICONE APPLICATION. THE CURRENT DESIGN CONTROLS FOR SILICONE RESIDUALS ON THE MIDDLE SHAFT INCLUDE A MAXIMUM LIMIT WITH RESPECT TO VASCULAR RESPONSE AND MINIMUM AMOUNT AS MECHANICALLY TESTED BY MEASURING THE FORCE TO RETRACT THE MIDDLE SHAFT FROM THE STENT SIMILAR TO THE DEPLOYMENT MECHANISM. THE EXACT ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED BY REVIEW OF THE RETURNED DEVICE AND MANUFACTURING RECORDS. MANIPULATION OF THE PULL GRIP AND OR RACK POST THUMBWHEEL DEPLOY IS A CONSIDERATION ALONG WITH AN EXCESSIVE LOAD TO FORCE THE PROXIMAL INNER FROM ITS TRACK. EXCESSIVE LOAD CAN RESULT FROM ANATOMY, SHEATH ENTRY ANGLES, SHEATH KINKS, AND POSSIBLY TIGHT LESIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE DEPLOYMENT DIFFICULTIES OCCURRED. THE LESION WAS SITUATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS OCCLUDED. THE OCCLUSION WAS PASSED VIA THE SUB INTIMAL SPACE WITH A NON BSC DEVICE. THE SEGMENT TO TREAT WAS REPORTED TO BE 35CM LONG. AN INNOVA 6MMX201MM STENT WAS OPENED AND FLUSHED. THE DEVICE WAS ADVANCED THROUGH A 6F INTRODUCER SHEATH AND OVER A NON-BSC .035 GUIDE WIRE. THE STENT DEPLOYMENT BEGAN USING THE THUMB WHEEL. AT 120MM THE STENT STOPPED TO DEPLOY, THE PHYSICIAN TRIED TO USE THE PULLBACK HANDLE TO FULLY DEPLOY THE STENT, BUT THE HANDLE DID NOT MOVE. AFTER SEVERAL ATTEMPTS, THE STENT DEPLOYED. IT WAS NOTED THAT THE .035 GUIDEWIRE BECAME STUCK IN THE DELIVERY SYSTEM AND WAS NOT POSSIBLE TO REMOVE. BOTH DEVICES WERE REMOVED TOGETHER. ON ANGIOGRAPHIC IMAGING THE MID SECTION OF THE STENT APPEARED TO BE STRETCHED. A NEW WIRE WAS INSERTED, A BALLOON WAS USED TO POST DILATE THE INNOVA STENT, AND ANOTHER NON BSC STENT WAS IMPLANTED TO FULLY COVER THE LESION AND THE DAMAGE STENT AREA. THE PATIENT REMAINED STABLE. A VESSEL RUPTURE WAS REPORTED AS NOT RELATED TO THE USED STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE DEPLOYMENT DIFFICULTIES OCCURRED. THE LESION WAS SITUATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS OCCLUDED. THE OCCLUSION WAS PASSED VIA THE SUB INTIMAL SPACE WITH A NON BSC DEVICE. THE SEGMENT TO TREAT WAS REPORTED TO BE 35CM LONG. AN INNOVA 6MMX201MM STENT WAS OPENED AND FLUSHED. THE DEVICE WAS ADVANCED THROUGH A 6F INTRODUCER SHEATH AND OVER A NON-BSC .035 GUIDE WIRE. THE STENT DEPLOYMENT BEGAN USING THE THUMB WHEEL. AT 120MM THE STENT STOPPED TO DEPLOY, THE PHYSICIAN TRIED TO USE THE PULLBACK HANDLE TO FULLY DEPLOY THE STENT, BUT THE HANDLE DID NOT MOVE. AFTER SEVERAL ATTEMPTS, THE STENT DEPLOYED. IT WAS NOTED THAT THE .035 GUIDEWIRE BECAME STUCK IN THE DELIVERY SYSTEM AND WAS NOT POSSIBLE TO REMOVE. BOTH DEVICES WERE REMOVED TOGETHER. ON ANGIOGRAPHIC IMAGING THE MID SECTION OF THE STENT APPEARED TO BE STRETCHED. A NEW WIRE WAS INSERTED, A BALLOON WAS USED TO POST DILATE THE INNOVA STENT, AND ANOTHER NON BSC STENT WAS IMPLANTED TO FULLY COVER THE LESION AND THE DAMAGE STENT AREA. THE PATIENT REMAINED STABLE. A VESSEL RUPTURE WAS REPORTED AS NOT RELATED TO THE USED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939180062070 15429891

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention