BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1162755 · Received September 16, 2008

    Report

    Report Number
    9616099-2008-02248
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE CYPHER SELECT 2.50X23 MM WAS RECEIVED. THE SHAFT WAS KINKED. THE BALLOON WAS NOT PLEATED, IT APPEARED AS IF IT HAD BEEN PARTIALLY INFLATED; DRY INFLATION MEDIA AND DRY BLOOD RESIDUES WERE OBSERVED ON THE UNIT. NO OTHER ANOMALY WAS OBSERVED. A REVIEW OF THE MFG DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MFG PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. STENT DISLODGEMENT IS A KNOWN COMPLICATION ASSOCIATED WITH STENT PLACEMENT. THE STENT DISLODGEMENT REPORTED BY THE CUSTOMER WAS CONFIRMED; HOWEVER, IT IS LIKELY THAT PROCEDURAL FACTORS, SUCH AS NEGATIVE PREP OUTSIDE THE PT AND INADVERTENT PARTIAL INFLATION OF THE DELIVERY SYSTEM PRIOR TO DEPLOYMENT, AND LESION CHARACTERISTICS, SUCH AS, CALCIFIED AND TORTUOUS, COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE EXACT CAUSE OF THE KINK ON THE SHAFT COULD NOT BE CONCLUSIVELY DETERMINED. CONTROLS ARE IN PLACE TO PREVENT THIS KIND OF DAMAGES FROM LEAVING THE FACILITY. CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT.

    Description of Event or Problem · 1

    THIS FEMALE PT WAS ADMITTED FOR CORONARY EVAL DUE TO CHEST PAIN. ANGIOGRAPHY REVEALED A CALCIFIED, 70% STENOSIS IN THE MID-LAD. THE VESSEL WAS DESCRIBED AS TORTUOUS. THE VESSEL WAS ACCESSED WITH AN EBU3.5 GUIDING CATHETER AND AN ABBOTT BMW GUIDE WIRE. THE LESION WAS PREDILATED SEVERAL TIMES WITH A MEDTRONIC SPRINTER 2.5X 12MM BALLOON. THEN THE 2.5X23MM CYPHER SELECT STENT WAS SELECTED. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. THE DEVICE WAS PREPPED ACCORDING TO THE IFU; HOWEVER, NEGATIVE PRESSURE WAS DRAWN ON THE DEVICE PRIOR TO INSERTION INTO THE PT. THE CYPHER DEVICE WAS ADVANCED TO THE TARGET SITE. THE PHYSICIAN DID NOT FEEL DIFFICULTY DURING ADVANCING, BUT WHEN THE STENT ARRIVED NEAR THE LESION, THE STENT DISLODGED. THE PHYSICIAN RETRIEVED THE STENT IMMEDIATELY WITH THE 2.5 X 12MM BALLOON. PCI WAS NOT COMPLETED. THE PHYSICIAN WILL CONDUCT THE PROCEDURE AT A LATER DATE. THERE WERE NO OTHER REPORTED COMPLICATIONS OR PT INJURY.

    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 13376965

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention EBU3.5 GUIDING CATHETER AND ABBOTT BMW GUIDE WIRE