BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1071604 · Received July 8, 2008

    Report

    Report Number
    9616099-2008-01695
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS PRODUCT IS SIMILAR TO US CYPHER.

    Description of Event or Problem · 1

    DURING A (PCI) PERCUTANEOUS CORONARY INTERVENTION, PRE-DILATION WITH A BALLOON (MAVERICK, 2.25/12MM) WAS CONDUCTED AND THEN CYPHER (2.5/28MM) WAS BEING DELIVERED TO THE TARGET LESION USING A GUIDE WIRE (RUNTHROUGH), BUT THE CYPHER BECAME STUCK AT THE SEVERE CALCIFICATION AND FLEXION PROXIMAL TO THE TARGET LESION. THEREFORE, THE PHYSICIAN TRIED TO ADVANCE THE CYPHER BY CONDUCTING PARALLEL WIRE TECHNIQUE WITH AN ADDITIONAL WIRE (NEO'S RINATO) AND HE MANAGED TO REDELIVER THE CYPHER BY PUSHING IT STRONGLY SEVERAL TIMES ALTHOUGH THERE WAS FRICTION. THE CYPHER WAS POSITIONED FOR IMPLANT AT THE TARGET LESION AND THEN SOON AFTER THE CYPHER WAS INFLATED, THE PHYSICIAN CONFIRMED THE BALLOON TO BE RUPTURED BECAUSE CONTRAST MEDIUM LEAKAGE WAS OBSERVED AT APPROX. 6 ATMOSPHERES. THE STENT WAS UNDER DILATED, AND SO POST-DILATION WAS CONDUCTED WITH A BALLOON (NC SPRINTER). THE IMPLANT OF THE STENT WAS COMPLETED AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WAS CLINICALLY USED AND ONLY THE (SDS) STENT DELIVERY SYSTEM WILL BE RETURNED FOR ANALYSIS. THE PATIENT'S AGE WAS UNKNOWN, BUT WAS A MALE. THE TARGET LESION WAS THE MID (CX) CIRCUMFLEX ARTERY WITH UNKNOWN IF THE LESION WAS A DE NOVO. THE VESSEL WAS HEAVILY CALCIFIED AND HIGHLY TORTUOUS. THERE WAS 75% STENOSIS. ADDITIONAL INFORMATION INDICATED THAT ALL THE PRODUCTS PROBABLY WERE PREP PER (IFU) INSTRUCTION FOR USE, AND NO LEAKS WERE OBSERVED DURING PREP, BUT LEAKS WERE NOTED DURING INFLATION OF THE BALLOON. THE SDS WAS DELIVERED THROUGH A LAUNCHER (7F EBU3.5SH), BUT THERE WAS NO INFORMATION REGARDING THE SHEATH INTRODUCER. THE CONTRAST TO SALINE CONCENTRATION WAS UNKNOWN, BUT USUALLY 1:1 AND THAT'S INDICATED IN OUR IFU. THEY DID NOT EXPERIENCE ANY DEFLATION DIFFICULTY. THE TYPE AND MANUFACTURER OF THE CONTRAST USED FOR THE INFLATION COULD NOT BE OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE.

    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 13386912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GC: LAUNCHER 7F EBU 3.5SH| INFLATION DEVICE: EVEREST| GW: RUNTHROUGH| BC: MEVERICK