BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2113113 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03867
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROMUS STENT DELIVERY SYSTEM (SDS) FOUND THE STENT IMPLANT WAS RETURNED LOOSE ON THE BALLOON. THERE WAS ONE FLARED PROXIMAL STRUT ON THE FIRST ROW OF THE STENT IMPLANT WHICH LIKELY RESULTED FROM THE STENT DISLODGEMENT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT AND NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. THE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. ANALYSIS ALSO NOTED THE STENT CRIMP IMPRESSIONS WERE FAINT ON THE BALLOON SUGGESTING THIS COULD HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. POTENTIAL CAUSES FOR STENT DISLODGEMENT, MAY INCLUDE: IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION FOR USE, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL OR HANDLING OF THE STENT DURING PREPARATION FOR USE. ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT AND CRIMPED STENT OUTER DIAMETER DURING MANUFACTURING. IN ADDITION, AS PART OF PRODUCT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR STENT DISLODGEMENT FORCE. A CONCLUSIVE CAUSE CAN NOT BE DETERMINED FOR THE REPORTED STENT DISLODGEMENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS REVEALED NO NONCONFORMING MATERIAL RECORDS RELATED TO THIS INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS HAVE BEEN REPORTED FOR STENT DISLODGEMENT FOR THIS LOT.

    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 REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT IMPLANT FELL OFF THE 3.0 X 28 MM PROMUS RX STENT DELIVERY SYSTEM (SDS) WHILE REMOVING THE SDS FROM THE PACKAGING HOOP. THE STENT IMPLANT DID NOT APPEAR DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. A NEW PROMUS WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT: THE TECHNICIAN THAT WAS SCRUBBING-IN SAID THE STENT CAME ENTIRELY OFF THE BALLOON. WHEN HE HANDED THE STENT DELIVERY SYSTEM TO THE PHYSICIAN TO PUT INTO THE GUIDE CATHETER, THE STENT WAS NOT ON THE BALLOON. THE STENT WAS FOUND HANGING HALFWAY OFF OF THE YELLOW PROTECTIVE SHEATH THAT COVERS THE STENT AND BALLOON.

    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 0110841

    Patients

    Seq Age Sex Outcome Treatment
    1