BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2132631 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04297
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. GUIDE WIRE: SION FIELDER. GUIDE CATH: TERUMO 6F IR. SHEATH: INTRODUCER SHEATH: 6F. PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO: PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE PATIENT ANATOMY WAS HEAVILY TORTUOUS, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY INTERACTION WITH THE TORTUOUS LESION AS RESISTANCE WAS MET IN THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE AND LOOSENED THE STENT ON THE BALLOON. SUBSEQUENT INTERACTION WITH THE LESION AS THE STENT DELIVERY SYSTEM (SDS) WAS POSITIONED IN THE LESION WOULD HAVE THEN LED TO THE STENT DISLODGEMENT. 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 COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR PHYSICAL RESISTANCE OR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCESS. 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 DURING A DISTAL RIGHT CORONARY ARTERY STENTING PROCEDURE, THE 3.5 X 15 MM PROMUS STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE HEAVILY TORTUOUS LESION SITE AFTER PRE-DILATATION. USING A TWO WIRE TECHNIQUE, THE PROMUS WAS ABLE TO CROSS THE LESION; HOWEVER, DURING POSITIONING OF THE PROMUS STENT, THE STENT DISLODGED. AN ATTEMPT WAS MADE TO POSITION THE SDS BALLOON INSIDE THE STENT TO DEPLOY IT AT THE TARGET LESION, BUT THE ATTEMPT FAILED. A NON-ABBOTT BALLOON CATHETER WAS ALSO UNABLE TO BE INSERTED INSIDE THE DISLODGED STENT. AFTER REWIRING, THE NON-ABBOTT BALLOON CATHETER WAS ABLE TO CROSS AND CRUSH THE DISLODGED STENT, WHICH WAS THEN EMBEDDED INTO THE VESSEL WALL AT THE TARGET LESION USING ANOTHER PROMUS STENT. 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 1011261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention