BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1973221 · Received January 28, 2011

    Report

    Report Number
    2024168-2011-00539
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 5, 2011
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. 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 AND/OR ACCESSORY DEVICES. TO HELP ENSURE THAT THE REPORTED STENT DISLODGMENT 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. THE PRODUCT WAS NOT RETURNED AND MAY HAVE AIDED IN THE INVESTIGATION. HOWEVER, THERE WAS NO REPORT OF ANY DAMAGE TO THE SDS OR STENT IMPLANT PRIOR TO USE, SUGGESTING THAT THE STENT DISLODGEMENT WAS A RESULT OF THE PROCEDURE. IT IS LIKELY THAT INTERACTION BETWEEN THE STENT AND GUIDING CATHETER CONTRIBUTED TO THE REPORTED DIFFICULTY REMOVING THE SDS, AS IT WAS REPORTED THAT THE PROMUS STENT BECAME CAUGHT ON THE TIP OF THE GUIDING CATHETER. IN THIS CASE, IT IS ALSO LIKELY THAT INTERACTION WITH THE GUIDING CATHETER CONTRIBUTED TO THE REPORTED STENT DISLODGMENT, WHICH REQUIRED RETRIEVAL OF THE DISLODGED STENT VIA THE USE OF A SNARE. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING WITHDRAWAL OF THE PROMUS STENT DELIVERY SYSTEM, THE STENT GOT CAUGHT ON THE GUIDING CATHETER AND DISLODGED ONTO THE GUIDE WIRE. A GOOSE NECK SNARE DEVICE WAS USED TO RETRIEVE THE STENT. NO PATIENT EFFECTS WERE REPORTED. 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 0070161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention