BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904768 · Received November 22, 2010

    Report

    Report Number
    2024168-2010-02462
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD ON THE BALLOON AND IN THE GUIDE WIRE LUMEN, WHICH IS CONSISTENT WITH HANDLING AND A GUIDE WIRE BEING LOADED INTO THE LUMEN. THE STENT IMPLANT WAS LOOSE ON THE DISTAL SHAFT, THUS CONFIRMING THE DISLODGMENT. HOWEVER, THERE WERE CRIMP MARKS ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. IT WAS FURTHER NOTED THAT THE FIRST FOUR ROWS OF THE PROXIMAL STENT STRUTS WERE MANGLED AND THE FIRST TWO ROWS OF DISTAL STRUTS WERE STRETCHED. THUS, THE DISTAL AND PROXIMAL STENT OUTER DIAMETERS (OD) COULD NOT BE MEASURED. THE MIDDLE STENT OUTER DIAMETER (OD) WAS OVERSIZED, HOWEVER, THIS MOST LIKELY OCCURRED AT THE TIME OF DISLODGEMENT AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON. THERE WAS NO REPORT OF ANY DAMAGE TO THE SDS OR STENT IMPLANT PRIOR TO USE, SUGGESTING A PRODUCT QUALITY DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE THAT THE STENT IMPLANT BECAME ENTANGLED WITH THE OTHER DEVICES INSIDE THE GUIDING CATHETER DURING ADVANCEMENT AND DISLODGED PROXIMALLY ONTO THE DISTAL SHAFT DURING FURTHER MANIPULATION, ALTHOUGH THIS CANNOT BE CONFIRMED. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT 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 REPORT. IN THIS CASE, A DEFINITIVE CAUSE OF THE STENT DISLODGEMENT AND SUBSEQUENT STENT DAMAGE CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON INSIDE THE GUIDE CATHETER. THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE CIRCUMFLEX (CX). AN ATTEMPT WAS MADE TO PLACE A STENT IN THE LAD AND THE CX SIMULTANEOUSLY. AFTER THE STENT WAS PLACED IN CX, AN ATTEMPT WAS MADE TO ADVANCE THE 3.5 X 18 PROMUS UP IN THE LAD, BUT THE STENT CAME OFF THE BALLOON IN THE GUIDE CATHETER. THE STENT WAS OBSERVED IN THE GUIDE CATHETER SO ALL DEVICES WERE REMOVED. THE LESIONS WERE RE-WIRED AND A NEW PROMUS STENT WAS USED IN THE LAD, BUT ALL OTHER DEVICES WERE THE SAME DEVICES AS USED BEFORE. THE CASE WAS COMPLETED SUCCESSFULLY BY IMPLANTING 2 STENTS WITH GOOD PATIENT OUTCOME. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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-CLONMEL 0060441

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR DIL CATH: 2.5X15 APEX, 3.5X15 NC QUANTUM APEX