BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2123713 · Received June 14, 2011

    Report

    Report Number
    2024168-2011-04175
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    February 10, 2011
    Report Date
    May 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE SHAFT AND ON THE BALLOON, CONSISTENT WITH THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE BALLOON, CONFIRMING THE REPORTED INFORMATION. THE MIDDLE OF THE STENT WAS BENT AND THERE WERE BENT STRUTS AT THE DISTAL END OF THE STENT. CRIMP MARKS WERE VISIBLE ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE PROXIMAL OUTER DIAMETERS OF THE STENT IMPLANT WERE MEASURED AND MET MANUFACTURING CRITERIA. THE DISTAL AND MIDDLE OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED TO THE STENT IMPLANT. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. TO ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. IN THIS CASE, IT IS POSSIBLE THE STENT WAS INADVERTENTLY HANDLED DURING PREPARATION, RESULTING IN THE REPORTED STENT DISLODGEMENT AS THE STENT WAS NOTED TO BE ON THE BALLOON DURING UNPACKING. ADDITIONAL HANDLING OF THE STENT DURING PACKING FOR RETURN ANALYSIS MAY HAVE CONTRIBUTED TO THE NOTED STENT DAMAGE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY USING THE PROMUS RX STENT DELIVERY SYSTEM, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. IT WAS THOUGHT THAT THE STENT WAS ON THE BALLOON WHEN THE PROCEDURE BEGAN, BUT THE STENT WAS LATER FOUND ON THE BACK TABLE AREA. THE BALLOON WAS NEVER PLACED UNDER PRESSURE IN THE ANATOMY. THE PROCEDURE WAS COMPLETED USING A NEW PROMUS STENT SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT AND NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0062441

    Patients

    Seq Age Sex Outcome Treatment
    1