BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1852289 · Received October 4, 2010

    Report

    Report Number
    2134265-2010-04376
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    May 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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

    IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT WAS RESTENOSIS OF THE 1ST RIGHT POSTEROLATERAL BRANCH INSTEAD OF RESTENOSIS OF THE RIGHT POSTERIOR DESCENDING ARTERY INITIALLY REPORTED.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2010-04272, 2134265-2010- 04517, 2134265-2010-04375, 2134265-2010-04271. SAME PATIENT AS: 2134265-2009-03516, 2134265-2010-01092, 2134265-2010-01091. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. LESION 1 WAS DE NOVO 75% STENOSED, 3.00MM IN DIAMETER AND 24.0MM LONG PORTION OF MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH AN UNKNOWN BALLOON AT 12 ATMS. A 3.00MMX24MM TAXUS EXPRESS2 STENT WAS IMPLANTED AT 18 ATMS. POST PROCEDURE VISUAL EVALUATION REVEALED 0% STENOSIS AND TIMI FLOW WAS 3. LESION 2 WAS A DE NOVO 90% STENOSED, 3.00MM IN DIAMETER AND 20.0MM LONG PORTION OF THE 1ST RIGHT POSTEROLATERAL (RPL). THE LESION WAS PREDILATED WITH TWO UNKNOWN BALLOONS AT 14 ATMS. A 3.00X24MM TAXUS EXPRESS2 STENT WAS IMPLANTED AT 18 ATMS AND A 2.50X16MM TAXUS EXPRESS2 STENT WAS IMPLANTED AT 10 ATMS IN THE LESION. THE LESION WAS POST DILATED WITH TWO SEPARATE BALLOONS. POST PROCEDURE VISUAL EVALUATION REVEALED 0% STENOSIS AND TIMI FLOW WAS 3. IN OCTOBER 2008, TARGET VESSEL REINTERVENTION WAS PERFORMED ON THE PROXIMAL AND DISTAL RCA. THE 3.00MM IN DIAMETER, 14.0MM LONG, 75% STENOSED LESION IN THE PROXIMAL RCA WAS TREATED WITH AN UNSPECIFIED BALLOON AND A TAXUS STENT. POST TREATMENT VISUAL INSPECTION REVEALED 0% STENOSIS. THE 3.00MM IN DIAMETER, 15.0MM LONG, 90% STENOSED LESION IN THE DISTAL RCA WAS TREATED WITH AN UNSPECIFIED BALLOON AND A TAXUS STENT. POST TREATMENT VISUAL INSPECTION REVEALED 0% STENOSIS. PATIENT OUTCOME WAS IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 2 DAYS LATER. IN (B)(6) 2010, THE PATIENT EXPERIENCED RESTENOSIS IN THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). IT WAS NOTED BY THE PHYSICIAN "THIS WAS AN IN-STENT RESTENOSIS OF THE TAXUS STENT". THE PATIENT WAS HOSPITALIZED AND A TARGET VESSEL RE-INTERVENTION WAS PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IMPROVED. A 2 YEAR FOLLOW-UP WAS PERFORMED, AND THERE WERE NO ANGINA SYMPTOMS. AT 4 DAYS LATER, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE 1ST RIGHT POSTEROLATERAL BRANCH. THE LESION WAS 90% STENOSED, 2.75MM IN DIAMETER AND 15MM LONG. THE LESION WAS DILATED WITH A BALLOON CATHETER. THERE WERE NO ISCHEMIC SYMPTOMS NOTED AT THE EVENT. RESIDUAL STENOSIS WAS 0%. IN (B)(6) 2010, THE PATIENT'S STATUS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897016250

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention