BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2080379 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03244
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    February 28, 2011
    Report Date
    April 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PATIENT ANATOMICAL INFORMATION WAS NOT PROVIDED WITH THE CASE INFORMATION WHICH MAY HAVE AIDED IN THE INVESTIGATION. IT IS POSSIBLE AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS 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 DURING MANIPULATION WOULD HAVE THEN LED TO THE STENT DISLODGEMENT. THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE; HOWEVER A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. IT WAS REPORTED SOME SLOW FLOW WAS EXPERIENCED DURING THE PROCEDURE AND THERE WAS A MILD PERI-PROCEDURAL ENZYME ELEVATION. A DAY LATER, THE PATIENT EXPERIENCED CHEST PAIN AND A NON-ST SEGMENT MYOCARDIAL INFARCTION. ANGINA, ISCHEMIA, AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, THE PART AND LOT NUMBERS WERE NOT REPORTED. TO ENSURE THE REPORTED DIFFICULTIES ARE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE RECEIVED BY MANUFACTURER WAS INADVERTENTLY ENTERED AS NA ON THE PREVIOUSLY FILED SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. LEFT MAIN STEM (LMS) WAS NORMAL. LAD STENTS WERE FOUND TO BE PATENT WITH TIMI 3 FLOW. PROXIMAL LEFT CIRCUMFLEX (CX) SHOWED MILD HAZINESS WITH GOOD FLOW IN THE LCX. THE PATIENT WAS PAIN FREE FOLLOWING HIS SECOND (B)(6) 2011, ANGIOGRAM. THE NSTEMI IS RECORDED AS RESOLVING ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. 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 VASCULARS DRUG ELUTING STENT IN THE US. THE STENT DELIVERY SYSTEM WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE FOUR OTHER PROMUS STENTS WILL EACH BE FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2011, DUE TO ACUTE CORONARY SYNDROME, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH DEPLOYMENT OF TWO DES STENTS, ONE TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND ONE TO THE SECOND OBTUSE MARGINAL. POST-PROCEDURE RESIDUAL STENOSIS AND TIMI FLOW WAS NOT REPORTED AT THE TIME OF THIS REPORT. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE INDEX PROCEDURE HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT RETURNED FOR A PLANNED STAGED PROCEDURE TO HIS LAD. THE TREATMENT TO THE MID LAD LESION PROVED VERY DIFFICULT. MULTIPLE RUNS WITH A ROTABLATOR WERE REQUIRED AND FOLLOWING THIS, IT PROVED VERY DIFFICULT TO PASS STENTS. IT WAS VERY DIFFICULT TO DELIVER THE STENT INITIALLY WITH LOSS OF THE FIRST STENT; HOWEVER, A SECOND STENT DEPLOYED WITH GOOD RESULT. USING A VARIETY OF TECHNIQUES INCLUDING A BUDDY WIRE, ANCHOR BALLOON AND MOTHER AND CHILD GUIDE CATHETER, THE MID LAD WAS STENTED WITH A NUMBER OF DES STENTS. SOME SLOW FLOW WAS EXPERIENCED DURING THE PROCEDURE AND THERE WAS A MILD PERI-PROCEDURAL ENZYME ELEVATION (CK 300, HSTNT 430). THE PATIENT WAS COMMENCED ON REOPRO BOLUS AND INFUSION AND HIS NITROGLYCERIN INFUSION WAS INCREASED TO 2.4 MLS PER HOUR DUE TO CONTINUED CHEST PAIN. THE PATIENT RETURNED TO THE CARDIAC CATHETERIZATION LABORATORY LATER THE SAME DAY DUE TO INFERIOR ST SEGMENT DEPRESSION REPORTED AS A NON-ST SEGMENT MYOCARDIAL INFARCTION (NSTEMI; REPORTED AS A SEPARATE SAE) AND ONGOING CHEST PAIN.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability STENT: PROMUS (X4)