BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073343 · Received May 1, 2011

    Report

    Report Number
    2024168-2011-03052
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    September 29, 2010
    Report Date
    February 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) PREVIOUSLY BEING ADVANCED OVER A GUIDE WIRE. THE STENT IMPLANT WAS DISLODGED FROM THE SDS. THE FULL LENGTH OF THE STENT IMPLANT WAS STRETCHED. 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 DISTAL BALLOON TAPER WAS BUNCHED. THERE WERE MULTIPLE BENDS THROUGHOUT THE FULL LENGTH OF THE HYPOTUBE. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO: IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. 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 UNKNOWN WHEN THE STENT DISLODGEMENT OCCURRED; HOWEVER IT IS POSSIBLE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT IN THE LESION, RESULTING IN DAMAGE TO THE STENT AND THE DISTAL TAPER OF THE BALLOON WRINKLING. NO DAMAGE WAS NOTED DURING THE INSPECTION PRIOR TO USE, WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. INTERACTION WITH THE LESION/ANATOMY DURING RETRACTION MAY HAVE LOOSENED THE STENT ON THE BALLOON AND FURTHER DAMAGED THE STENT. HANDLING DURING PACKAGING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS MAY HAVE ALSO CONTRIBUTED TO THE STENT DISLODGEMENT. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER NONE WAS AVAILABLE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT 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 DAMAGE OR DISLODGMENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITH LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATATION WITH AN UNKNOWN BALLOON CATHETER, THERE WERE "LACERATIONS ON THE STEMS" [DAMAGED STENT STRUTS] WHILE ATTEMPTING TO DEPLOY IN THE MID LEFT ANTERIOR DESCENDING ARTERY. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED A PARTIALLY DISLODGED STENT.

    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 9120741

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR