BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1911970 · Received December 1, 2010

    Report

    Report Number
    2134265-2010-05339
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    December 8, 2009
    Report Date
    November 4, 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

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS : MFR# 2134265-2009-07140. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED STENOSIS. DURING THE INDEX PROCEDURE IN (B)(6) 2008, THE 75% STENOSED DE NOVO TARGET LESION WAS 35.0MM LONG WITH A 2.90MM REFERENCE VESSEL DIAMETER LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED AND TREATED WITH THE PLACEMENT OF A 2.75X32MM TAXUS EXPRESS2 STENT. POST-DILATION WAS PERFORMED WITH RESIDUAL STENOSIS 0% AND TIMI FLOW 3. THE PATIENT CONTINUED HOSPITALIZATION FOR OBSERVATION OF "TAKOTSUBO CARDIOMYOPATHY" AND WAS DISCHARGED 9 DAYS LATER ON BAYASPIRIN AND PLAVIX. IN (B)(6) 2009, A 9 MONTH FOLLOW-UP CORONARY ANGIOGRAM (CAG) WAS PERFORMED REVEALING 90% STENOSIS IN THE PROXIMAL RCA. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH AN UNKNOWN BALLOON AND THE PLACEMENT OF A NON-BSC STENT. POST VISUAL INSPECTION REVEALED 0% RESIDUAL STENOSIS. "THE PATIENT HAD NO ISCHEMIC SYMPTOMS." POST PROCEDURE TIMI FLOW REMAINED 3 AND THE STENOSIS WAS RESOLVED. THE PATIENT WAS DISCHARGED 1 DAY LATER ON BAYASPIRIN AND PLAVIX. THE PATIENT CONDITION WAS "RESOLVED". IN (B)(6) 2009, STENOSIS IN THE MID RCA WAS NOTED. THE 90% STENOSED TARGET LESION WAS 2.75MM IN DIAMETER AND 30.0MM LONG. THE PATIENT WAS HOSPITALIZED AND A TARGET VESSEL REVASCULARIZATION WAS PERFORMED. THE LESION WAS DILATED WITH A CUTTING BALLOON. "THE PATIENT HAD NO ANY ISCHEMIC SYMPTOMS AT THE EVENT." RESIDUAL STENOSIS WAS 0%. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT OUTCOME IMPROVED. A 2-YEAR FOLLOW-UP WAS PERFORMED IN (B)(6) 2010. THE PATIENT HAD NO ANY ANGINAL SYMPTOMS.

    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 UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R