BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073097 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03012
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE PATIENT ANATOMICAL INFORMATION WAS NOT REPORTED WITH THE CASE INFORMATION WHICH MAY HAVE AIDED THE INVESTIGATION. IT IS POSSIBLE THAT THE STENT INTERACTED WITH THE PATIENT ANATOMY, CAUSING DAMAGE TO THE STENT. FURTHER MANIPULATION OF THE STENT AFTER THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PATIENT ANATOMY MAY HAVE CONTRIBUTED TO ULTIMATELY THE STENT DISLODGING. RETURN OF THE PROMUS SDS MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. 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. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT MAY HAVE CONTRIBUTED TO THIS EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT 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. GUIDE WIRE: RUNTHROUGH, CHOICE (X2), BMW. GUIDE CATH: LAUNCHER JR4.0, LAUNCHER JL4.0 AND EBU 4.0. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN STENT, THOUGHT POSSIBLY TO BE A PROMUS, DISLODGED AFTER BEING REMOVED FROM THE BODY. IT IS UNKNOWN IF THE DISLODGED STENT WAS A PROMUS OR A NON-ABBOTT STENT BECAUSE BOTH DEVICES WERE USED DURING THE PROCEDURE AND ONLY THE STENT WAS SAVED. NO ADVERSE 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 AV-TEMECULA-CT 9120142

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR