BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2180369 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03234
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    May 21, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2011-02580. IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH SUB ACUTE THROMBOSIS AND MI. THE PROCEDURE TREATED THE 70% STENOSED ECCENTRIC LONG LESION LOCATED IN THE SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). USING THE RIGHT FEMORAL APPROACH, MULTIPLE INFLATIONS WERE MADE WITH AN 2.5MM CUTTING BALLOON AND THEN PRE-DILATED WITH AN UNSPECIFIED 2.5X16MM BALLOON. NEXT THE VESSEL WAS STENTED WITH TWO MONORAIL ION STENTS, A 2.5X16MM STENT PLACED IN THE MID RCA AND A 3.0X16MM STENT PLACED IN THE MID-PROXIMAL RCA. POST DILATION WAS PERFORMED WITH A 3.0X20MM NON COMPLAINT BALLOON TO 18 ATM'S RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT TOLERATED THE PROCEDURE WELL, BUT IT WAS NOTED THAT THE PATIENT EXPERIENCED JAW PAIN WITH BALLOON INFLATION. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PLAVIX. THREE DAYS POST THE PROCEDURE, THE PATIENT PRESENTED WITH ACUTE NAUSEA, CHEST DISCOMFORT AND DYSPNEA. ELECTROCARDIOGRAM RESULTS REVEALED AN ACUTE INFERIOR MI. REVASCULARIZATION USING THE RIGHT FEMORAL APPROACH CONFIRMED AN OCCLUSION OF THE MID RCA AND THROMBUS THROUGHOUT THE VESSEL WITH POOR FLOW NOTED. THE RV BRANCH WAS ALSO OCCLUDED. AN UNSPECIFIED GUIDEWIRE WAS ADVANCED AND MET DIFFICULTY CROSSING THE DISTAL PORTION OF THE STENT SO A DECISION WAS MADE TO PERFORM ANGIOPLASTY WITH A 2.5MM BALLOON WITH SEVERAL INFLATIONS. NEXT AN ASPIRATION CATHETER WAS USED WITH INTERVAL IMPROVEMENT BUT SOME RESIDUAL THROMBUS AND SLOW FLOW WERE NOTED IN THE DISTAL VESSEL. THE ST SEEMED TO BE SLIGHTLY BETTER WITH SOME RESTORATION OF FLOW, HOWEVER THE PATIENT DEMONSTRATED INITIAL BRADYCARDIA AND HYPOTENSION AND THE HYPOTENSION WAS TREATED WITH MEDICATION. FURTHER ASPIRATION WAS PERFORMED AND THEN FINALLY BALLOON ANGIOPLASTY WAS PERFORMED WITH A 3MM BALLOON AT SEVERAL LOCATIONS RESULTING IN EXCELLENT ANGIOGRAPHIC RESULT, NO RESIDUAL BLOCKAGE AND NORMAL FLOW INTO THE DISTAL BRANCHES. THE PATIENT WAS DISCHARGED IN STABLE CONDITION 5 DAYS AFTER BEING READMITTED AND WAS PRESCRIBED EFFIENT SINCE SHE HAD BEEN ON PLAVIX AT THE TIME OF THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416300

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 2.5X16MM ION STENT