BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932307 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02809
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    April 27, 2009
    Report Date
    November 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD VISIBLE ON THE BALLOON AND IN THE GUIDE WIRE LUMEN, WHICH IS CONSISTENT WITH THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WAS A BEND IN THE STENT BETWEEN THE THIRD AND FORTH ROWS OF DISTAL STRUTS. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED KINK. ANALYSIS NOTED A KINK IN THE INNER MEMBER 1.5 MM DISTAL TO THE DISTAL BALLOON MARKER AND A KINK IN THE SOFT TIP .5MM DISTAL TO THE CLEAR GAP, AND MULTIPLE KINKS AND BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. A KINK CAN OCCUR DURING MANUFACTURING, REMOVAL FROM THE PACKAGING AT THE ACCOUNT OR FROM HANDLING OF THE PRODUCT DURING PREPARATION FOR USE. TO HELP ENSURE THIS DAMAGE IS NOT THE RESULT OF THE MANUFACTURING PROCESS, ALL SDS ARE 100% VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS, INCLUDING AT THE POINT THAT THE PRODUCT IS INSERTED INTO THE DISPENSER COIL. IN THIS CASE, THE PATIENT ANATOMY WAS TORTUOUS AND CALCIFIED WHICH LIKELY CONTRIBUTED TO THE NOTED KINKS. IT WAS REPORTED POST PROCEDURE; THE PATIENTS CARDIAC ENZYMES WERE NOTED TO BE ELEVATED. THE SITE REPORTED AN EVENT OF TROPONIN ELEVATION OCCURRING POST INDEX PROCEDURE AND PRIOR TO DISCHARGE ON (B)(6) 2009. TROPONIN ELEVATION WAS CONSISTENT WITH PROTOCOL DEFINITION OF MI. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION (MI) AS LISTED IN THE PROMUS IFU; IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED KINKS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2009, THE PATIENT UNDERWENT STENTING IN THE DISTAL, TORTUOUS, AND CALCIFIED RIGHT CORONARY ARTERY (RCA) WITH A 2.5 X12 NON-ABBOTT BARE METAL STENT AFTER TWO 3.0 X 12 PROMUS STENTS WERE UNABLE TO CROSS THE LESION. DURING ADVANCEMENT OF THE FIRST 3.0 X 12 PROMUS, THE SHAFT SEPARATED OUTSIDE OF THE PATIENT'S BODY WHEN THE PROMUS WAS PUSHED REALLY HARD. THERE WAS NO DIFFICULTY REMOVING THE 3.0 X 12 PROMUS FROM THE PATIENT. THE SECOND PROMUS STENT SHAFT KINKED DURING ADVANCEMENT. AFTER THE PROCEDURE, THE PATIENT'S TROPONIN ELEVATION WAS ELEVATED AND THE PATIENT WAS DIAGNOSED WITH A NON Q-WAVE MYOCARDIAL INFARCTION (MI). THERE WAS NO REPORTED INTERVENTION FOR THE MI. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) 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-TEMECULA-CT 8102061

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Disability 3.0 X 12 MM PROMUS (1009541-12B, (B)(4))