BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS2 MONIRIAL CORONARY STENT

    MDR report key: 726770 · Received June 15, 2006

    Report

    Report Number
    6000093-2006-01110
    Event Type
    Injury
    Date Received
    June 15, 2006
    Date of Event
    October 20, 2005
    Report Date
    May 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 7828106 HAVE BEEN REVIEWED, AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SEVEN DAYS FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, A STENT THROMBOSIS OCCURRED. THE PT INITIALY PRESENTED TO ENROLLING HOSP WITH AN ARRHYTHMIA (EITHER FIBRILLATION OR SUPRA-VENTRICULAR TACHYCARDIA). THE INDEX PROCEDURE AND TREATED ONE LESION. THE LESION WAS LOCATED IN THE RAMUS. IT WAS 90% STENOSED, 2.25MM IN DIAMETER AND 10MM IN LENGTH. THE LESION WAS PRE-DILATED WITH A MAVERICK BALLOON AT 9 ATMS. THE PHYSICIAN PLACED ONE BARE METAL EXPRESS2 2.25 X 20MM STENT OVER THE LESION. THE RESULTS WERE 0% RESIDUAL STENOSIS WITH TIMI-3 FLOW. THE PT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND PLAVIX. SEVEN DAYS FOLLOWING THE INDEX PROCEDURE, THE PT BEGAN TO EXPERIENCE "CRUSHING CHEST PAIN,, NEAR SYNCOPE AND HYPOTENSION." THE PT WENT TO SEE HER FAMILY PHYSICIAN. THE PHYSICIAN TRANSFERRED HER TO THE EMERGENCY DEPT. THE PT WAS TAKEN TO THE CATH LAB WHER IT WAS NOTED THAT THE PT HAD MARKED THROMBOSIS IN THE STENT TREATED REMUS. TO TREAT THE THROMBOSIS, THE PT WAS GIVEN ASPIRIN (324MG), PLAVIS (300MG), HEPARIN (3700 UNITS), AND INTEGRILIN. THE PHYSICIAN PLACED 3 PIXEL STENTS, A 2.00 X 8MM, A 2.00 X 18MM, AND A 2.25 X 23MM. IT WAS REPORTED THAT THE PT WAS NOT TAKING ASPIRIN AS INSTRUCTED AFTER THE INITIAL PROCEDURE BECAUSE OF AN UPSET STOMACH;HOWEVER, SHE WAS PRESCRIBED PLAVIX. THE PT WAS DISCHARGED FIVE DAYS LATER. THE DEVICE RELATIONSHIP WAS "DEFINITELY RELATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONIRIAL CORONARY STENT BALLOON EXPANDABLE STENT MAF BOSTON SCIENTIFIC CORP. 2.25 X 20MM 7828106

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization