BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2060274 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02675
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD ON THE DISTAL SHAFT AND CONTRAST IN THE INFLATION LUMEN AND BALLOON. IN ADDITION, THERE WERE CRIMP MARKS BETWEEN THE MARKERS ON THE TIGHTLY FOLDED BALLOON THAT INDICATED THAT THE STENT IMPLANT HAD BEEN PROPERLY POSITIONED AT THE TIME OF MANUFACTURE. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE PRODUCT WAS PREPARED FOR USE AND INSERTED IN THE BODY, BUT THE BALLOON WAS NOT INFLATED. THE STENT IMPLANT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) BALLOON AND WAS NOT RETURNED. THE PROTECTIVE SHEATH WAS ALSO NOT RETURNED. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS INCLUDING BUT ARE 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. 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. IN THIS CASE, IT IS LIKELY THAT THE 95% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION CONTRIBUTED TO THE STENT DISLODGEMENT, RESULTING IN A FOREIGN BODY IN THE PATIENT AND REQUIRED ADDITIONAL THERAPY/NON-SURGICAL TREATMENT. A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THAT THERE WERE SCATTERED LESIONS IN A HIGHLY CALCIFIED RIGHT CORONARY ARTERY (RCA). BALLOON DILATATIONS WERE PERFORMED IN THE POSTERIOR DESCENDING ARTERY AND DISTAL AND MID RCA. THE POST-DILATATION IMAGES STILL SHOW SIGNIFICANT STENOSES AT THE AREAS OF DILATATION. THE FINAL IMAGES SHOW A FAINT LINEAR SHADOW IN THE MID RCA. THE CLINICAL SPECIALIST CONCLUDED THAT THOUGH FAINT, AN UNEMPLOYED STENT IS VISIBLE IN THE MID RCA, CONFIRMING THE INCIDENT DESCRIPTION. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT AND NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO DEPLOY THE PROMUS RX STENT IN THE MODERATELY TORTUOUS AND CALCIFIED, ECCENTRIC RIGHT CORONARY ARTERY; HOWEVER, THE STENT DISLODGED. THE STENT COULD NOT BE LOCATED AND WAS NOT RETRIEVED FROM THE PATIENT AND THE PATIENT HAD A BALLOON PUMP INSERTED AT A LATER TIME. THE PATIENT WAS ALSO TAKEN TO SURGERY FOR A CORONARY ARTERY BYPASS GRAFT. SURGERY WAS SUCCESSFULLY PERFORMED TO TREAT THE LESION, BUT THE STENT WAS NOT REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 0111661

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other