BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1842741 · Received September 23, 2010

    Report

    Report Number
    9616099-2010-00713
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFLATION DEVICE: BOSTON SCIENTIFIC; GW: SION; GC: MACH1 6F FR4; BC: LACROSSE 3.0/15MM, HIRYU 3.25/10MM; SHEATH: RADIFOCUS. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND NO PROBLEMS WERE NOTED. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. NO KINKS OR BENDS WERE NOTED IN THE CATHETER BODY/SHAFT. THE SAME INFLATION DEVICE WAS USED WITH ANOTHER DEVICE SUBSEQUENT TO THE REPORTED PRODUCT ISSUE. THERE WAS NO REPORTED DIFFICULTY OR RESISTANCE/FRICTION REPORTED DURING ADVANCEMENT THROUGH THE HEMOSTATIC VALVE, GUIDING CATHETER OR ACCESSING THE LESION. THE BALLOON DEFLATED, AND RE-WRAPPED NORMALLY. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE BALLOON OF A 3.0X23MM CYPHER SELECT + RUPTURED WHILE INFLATING AT 10 ATM. THE SDS WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE CYPHER STENT WAS POST-DILATED WITH A BALLOON CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN DID NOT NOTE ANY ANOMALIES UPON INSPECTION AND PREPARATION OF THE DEVICE PRIOR TO USE. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS REPORTED TO BE: DE NOVO, SLIGHTLY TORTUOUS, MODERATELY CALCIFIED, AND A 90% STENOSIS. THE LESION WAS PRE-DILATED AND THERE WAS NO DIFFICULTY DELIVERING THE PRODUCT TO THE LESION. THERE WAS NO PROBLEM ENCOUNTERED ADVANCING, TRACKING OR REMOVING THE DEVICE FROM THE PATIENT. BALLOON RUPTURE WAS CONFIRMED BY CONTRAST MEDIUM LEAKAGE UNDER ANGIOGRAPHY AND BACK-FLOW OF BLOOD INTO THE INFLATION DEVICE. THE MANUFACTURER OF THE INFLATION DEVICE WAS BOSTON. INFORMATION ABOUT THE TYPE OF CONTRAST AND SALINE RATIO USED WAS NOT AVAILABLE BUT IT WAS PRESUMED TO BE 1:1. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO EXTENSIVE ANALYSIS COULD BE PERFORMED. A DHR REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE VESSEL CHARACTERISTICS, SPECIFICALLY THE MODERATE CALCIFICATION, THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN DELIVERED THE CYPHER SELECT PLUS 3.0 X 23 MM STENT DELIVERY SYSTEM (SDS) TO THE INTENDED TARGET LESION AND THE BALLOON BURST/RUPTURED AT 10 ATM. WHICH WAS CONFIRMED BY CONTRAST LEAKAGE AND BLOOD RETURN INTO THE INFLATION DEVICE. THE CYPHER SDS WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE CYPHER STENT WAS POST-DILATED WITH A HIRYU 3.25 X 10 MM BALLOON CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN DID NOT NOTE ANY ANOMALIES UPON INSPECTION OF THE DEVICE PRIOR TO USE. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS REPORTED TO BE: DE NOVO, SLIGHTLY TORTUOUS, MODERATELY CALCIFIED, AND A 90% STENOSIS. THE LESION WAS PRE-DILATED WITH A LACROSSE 3.0 X 15 MM BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 15096328

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R