BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BX SONIC STENT DELIVERY SYSTEM (OUS RX)

    MDR report key: 897070 · Received August 10, 2007

    Report

    Report Number
    9616099-2007-01546
    Event Type
    Injury
    Date Received
    August 10, 2007
    Date of Event
    January 5, 2006
    Report Date
    March 22, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WITH A MEDICAL HISTORY TREATED HYPERTENSION, TREATED HYPERLIPIDEMIA TREATED (DIABETES TYPE: NIDDM II) AND UNSTABLE ANGINA (TYPE IIB) WAS ADMITTED FOR THE INDEX PROCEDURE FOR A PCI (PERCUTANEOUS CORONARY INTERVENTION) OF THE MID-(LAD) LEFT ANTERIOR DESCENDING ARTERY WITH A 95% STENOSIS AND FIRST DIAGONAL BRANCH WITH 85% STENOSIS. THE MID-LAD LESION WAS TYPE B2 WITH NO CALCIFICATION OR THROMBUS, AND A TIMI TWO FLOW. THE LESION LENGTH WAS 23 MM AND THE VESSEL DIAMETER WAS 3 MM. THE LESIONS WERE PRE-DILATED WITH AN UNKNOWN 3 X 20 MM ANGIOPLASTY BALLOON UP TO 16 ATMOSPHERES. A DISSECTION OCCURRED DURING THE ANGIOPLASTY IN THE D1 BRANCH. A 3X23 MM BX SONIC STENT WAS DEPLOYED IN THE MID-LAD AT 16 ATMOSPHERES AND SECOND STENT 2.75X28 MM WAS IMPLANTED AT 12 ATMOSPHERES TO COVER THE DISSECTION. NO POST DILATION WAS CONDUCTED. THE FINAL TIMI FLOW WAS THREE. THE FIRST DIAGONAL BRANCH WAS PRE-DILATED WITH AN UNKNOWN 2.5X15 MM ANGIOPLASTY BALLOON AT 16 ATMOSPHERES. NO STENT WAS DEPLOYED AND A 30% RESIDUAL STENOSIS REMAINED. THE FINAL TIMI FLOW WAS THREE. AFTER THE STENTS WERE DEPLOYED, NO OTHER LESION REMAINED UNTREATED. THE RESIDUAL STENOSIS WAS 9%. DURING THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE NON-Q MI WITH NO CHEST PAIN, ELEVATED CPK (401) (NORMAL 24-195), CPK-MB 48 (NORMAL <5), NO EKG CHANGES. THE MI LOCATION WAS NOT IDENTIFIABLE AND WAS RELATED TO THE TARGET VESSEL, PROCEDURE OR POST INTERVENTION. THE TREATMENT WAS MEDICAL AND THE PATIENT RECOVERED. THE CEC DETERMINATION WAS HIGHLY PROBABLE RELATED TO THE PROCEDURE (SIDE BRANCH CLOSURE AFTER STENT IMPLANTATION). PER THE DESERT STUDY, EIGHT MONTHS AFTER UNDERGOING A (PCI) PERCUTANEOUS INTERVENTION, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA (CCS40). THE ANGIOGRAM REVEALED A 90% IN STENT STENOSIS OF THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS WITHOUT THROMBUS, AND THE TIMI FLOW WAS THREE. THE LESION WAS TREATED WITH TWO STENTS. A 50% STENOSIS WAS NOTED IN THE FIRST DIAGONAL BRANCH WITH A TIMI FLOW OF THREE, BUT THE LESIONS WERE NOT TREATED. THE PATIENT RECOVERED. THE EVENT WAS UNRELATED TO THE PROCEDURE, AND ACCORDING TO THE CEC DETERMINATION, THE EVENT WAS MACE-HIGHLY PROBABLE RELATED TO THE DEVICE. NO RELEVANT LABORATORY OR TEST DATA WAS AVAILABLE. THE PATIENT'S CURRENT STATE OF HEALTH WAS IS NORMAL. THE LOT NUMBERS WERE UNK. THE PATIENT WAS COMPLAINT WITH MEDICAL THERAPY THAT CONSISTED OF CLOPIDOGREL AND ASPIRIN. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE US; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS IS THE FIRST OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT # 9616099-2006-00452 AND 9616099-2007-01546. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    PER THE STUDY, EIGHT MONTHS AFTER UNDERGOING A (PCI) PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA (CCS40). THE ANGIOGRAM REVEALED A 90% IN STENT STENOSIS OF THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS WITHOUT THROMBUS, AND THE TIMI FLOW WAS THREE. THE LESION WAS TREATED WITH TWO STENTS. A 50% STENOSIS WAS NOTED IN THE FIRST DIAGONAL BRANCH WITH A TIMI FLOW OF THREE, BUT THE LESIONS WERE NOT TREATED. THE PATIENT RECOVERED. THE EVENT WAS UNRELATED TO THE PROCEDURE, AND ACCORDING TO THE CEC DETERMINATION, THE EVENT WAS MACE-HIGHLY PROBABLE RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC STENT DELIVERY SYSTEM (OUS RX) CORONARY SDS/STENTS MAF CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R