BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 2001163 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00413
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR # 2134265-2011-00336 AND 2134265-2011-00434. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A LOSS OF BLOOD FLOW AND REMOVAL DIFFICULTY OCCURRED. THE 90% LESION BEING TREATED WAS LOCATED IN THE SEVERELY DISEASED SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL (OM). WITHIN THE VESSEL THERE WERE 2 UNIDENTIFIED PREVIOUSLY IMPLANTED PROXIMAL STENTS, FOLLOWED BY THE LESION BEING TREATED, AND A DISTAL UNIDENTIFIED STENT. A FILTERWIRE AND IQ WIRE WERE PLACED, USING A BUDDY WIRE TECHNIQUE. DIFFICULTY PLACING BOTH WIRES TOOK AN ¿EXCEEDINGLY LONG TIME¿ AS THE WIRES WERE GETTING CAUGHT ON AREAS THROUGHOUT THE VEIN GRAFT. HOWEVER, AFTER PLACEMENT OF THE FILTERWIRE (PRIOR TO USE OF THE STENT), THERE WAS 'ESSENTIALLY' NO FLOW IN THE VEIN GRAFT. THE LESION WAS PREDILATED WITH A 3.5X20MM APEX BALLOON, RESTORING FLOW. A SIGNIFICANT DAMPENING OF THE PRESSURE WAVE FORM WAS IDENTIFIED. THE PHYSICIAN ATTEMPTED TO PLACE A 3.5X28MM TAXUS LIBERTE IN THE MID PORTION, BUT WAS UNABLE TO CROSS THE MID PORTION. THEREFORE THE PHYSICIAN DEPLOYED THE STENT FROM THE OSTIUM TO THE PROXIMAL PORTION, INFLATED 4 TIMES TO 12-18ATMS FOR 18-29 SECONDS. AFTER PLACEMENT OF THIS STENT THE DAMPENING OF THE PRESSURE WAVE FORM WAS NOT SEEN. THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER 3.5X38MM TAXUS LIBERTE STENT, BUT WAS UNABLE TO CROSS THE MID PORTION OF THE LESION. THE FILTERWIRE WAS THEN REMOVED AS IT HAD LOST POSITIONING DURING ONE OF THE STENT PASSES. THE FILTERWIRE BECAME WRAPPED UP WITH THE FIRST IQ WIRE AND THE ENTIRE SYSTEM HAD TO BE REMOVED AND A NEW IQ WIRE WAS PLACED. BALLOON DILATATION WAS PERFORMED WITH THE SAME 3.5X20MM APEX BALLOON; TOTAL OF 4 INFLATIONS WERE MADE FROM 12-14ATMS FOR 15-22 SECONDS. THE PHYSICIAN ATTEMPTED TO PLACE THE SAME 3.5X38MM TAXUS LIBERTE STENT. HOWEVER, THE STENT WOULD NOT PASS THROUGH THE PROXIMAL STENT. THE PROXIMAL STENT WAS DILATED AGAIN WITH A 4.0X30MM QUANTUM APEX, 3 TIMES TO 20ATMS 18-33 SECONDS. THE PHYSICIAN ATTEMPTED TO PLACE THE SAME 3.5X38MM TAXUS LIBERTE STENT AND WAS ABLE TO REACH THE MID PORTION BUT COULD NOT ADVANCE ANY FURTHER. UPON WITHDRAWAL THE STENT CAUGHT ON THE PREVIOUSLY PLACED PROXIMAL STENT AND DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). FLOW REMAINED ADEQUATE EVEN THOUGH THE DISLODGED STENT WAS SOMEWHAT CRUSHED TOWARD THE PROXIMAL PORTION. THE PHYSICIAN ATTEMPTED TO INFLATE THE DISLODGED STENT WITH A 4.0X20MM QUANTUM APEX, BUT WAS UNABLE TO CROSS THROUGH THE STENT. A 3.0X20MM APEX WAS ABLE TO INFLATE THE STENT, 3 INFLATIONS WERE MADE TO 14ATMS FOR 18-21 SECONDS. THEN THE PREVIOUS 4.0X20MM QUANTUM APEX WAS USED TO FURTHER INFLATE BOTH OF THE TAXUS LIBERTE STENTS, 5 INFLATIONS WERE MADE TO 20ATMS FOR 13-18 SECONDS. THERE WAS EXCELLENT FLOW IN THE VESSEL. HOWEVER, THERE WAS HAZINESS AT THE MAIN LESION. A 3.0X18MM PROMUS STENT WAS IMPLANTED IN THE MID PORTION, INFLATED TO 16ATMS FOR 30 SECONDS. A 3.0X23MM PROMUS STENT WAS ALSO IMPLANTED IN THE PROXIMAL TO MID PORTION, INFLATED TO 16ATMS FOR 22 SECONDS. THE STENTS WERE POST DILATED WITH A 4.0X30MM QUANTUM BALLOON, INFLATED 7TIMES TO 20ATMS FOR 15-27 SECONDS. LESS THAN 10% RESIDUAL STENOSIS REMAINS THROUGHOUT THE STENTED AREA. TIMI FLOW IS 3. MEDICATIONS GIVEN INCLUDED: HEPARIN AND ANGIOMAX. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS FINE. PER THE PHYSICIAN, "IT WAS A VERY EXTRAORDINARILY COMPLEX PROCEDURE, BUT ULTIMATELY SUCCESSFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201001900

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention IQ GUIDE WIRE| 3.5X20MM APEX BALLOON| (2) 3.5X38MM TAXUS LIBERTE LONG STENTS