BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2081645 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03288
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE SHAFT AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND HANDLING. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE BALLOON. THE ENTIRE LENGTH OF THE STENT WAS STRETCHED. THERE WAS ONE BROKEN PROXIMAL STRUT ON THE STENT IMPLANT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WERE MULTIPLE BENDS IN THE ENTIRE LENGTH OF THE HYPOTUBE. SEVERAL ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION AS TO WHEN THE STENT DISLODGMENT MAY HAVE OCCURRED; HOWEVER, NO INFORMATION WAS PROVIDED. IT IS POSSIBLE THE STENT WAS DAMAGED DURING THE FAILED ATTEMPT TO CROSS THE LESION AND FURTHER HANDLING DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS MAY HAVE CONTRIBUTED TO THE STENT DISLODGING AND BREAKING, AND THE NOTED BENDS IN THE HYPOTUBE. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE; HOWEVER, A CONCLUSIVE CAUSE FOR THE NOTED STENT DISLODGEMENT COULD NOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO INCIDENTS REPORTED FOR DISLODGED OR BROKEN STENTS FOR THIS LOT. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE.

    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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS DISLODGED FROM THE BALLOON AND APPEARS TO HAVE BEEN SNARED FROM THE ANATOMY.

    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 0092161

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention