BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2943998 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00326
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    October 6, 2011
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME PATIENT AS MDR ID#: 2134265-2013-00325, 2134265-2013-00327, 2134265-2013-00328. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD UNSTABLE ANGINA AND IN-STENT RESTENOSIS. IN (B)(6) 2007, THE PATIENT WAS DIAGNOSED FOR STABLE ANGINA (CCS CLASSIFICATION 1) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WITH 80% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. FOLLOWING PRE-DILATION USING A 2.25X15MM MAVERICK BALLOON CATHETER AND PLACEMENT OF A 2.25X24MM TAXUS PERSEUS STENT, A SMALL EXTRA LUMINAL DISSECTION WAS NOTED IN THE DIST RCA. THIS WAS SUBSEQUENTLY COVERED WITH A 2.25X12MM TAXUS PERSEUS STENT, WITH 0% RESIDUAL STENOSIS. IN (B)(6) 2010, THE PATIENT HAD UNSTABLE ANGINA. A TAXUS LIBERTE STENT WAS PLACED IN THE RAMUS INTERMEDIUS. IN (B)(6) 2011, ANGIOGRAPHY REVEALED 80% IN-STENT RESTENOSIS WITHIN THE STUDY STENTS THE IN THE MID AND DIST RCA. NO INTERVENTION WAS PERFORMED AND THE PATIENT WAS TREATED MEDICALLY. IN (B)(6) 2012, THE PATIENT PRESENTED WITH CHEST DISCOMFORT. THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA PECTORIS AND WAS HOSPITALIZED ON THE SAME DAY. THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE WITH SAPHENOUS VEIN GRAFT (SVG) TO RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) AND SVG TO RAMUS INTERMEDIUS. POST OPERATION THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND WAS SUBSEQUENTLY TREATED WITH AMIODARONE, BETA BLOCKERS AND COUMADIN BECAUSE OF PERSISTENCE OF ATRIAL FIBRILLATION. THE PATIENT RETURNED TO SINUS RHYTHM. THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47430 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692 9517199

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R