BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3182239 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03855
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: SION, RUNTHROUGH EXTRAFLOPPY; GUIDE CATH: LAUNCHER LA6SL3.5. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. STENT IMPLANT DAMAGE, CONTAMINATION/FOREIGN MATERIAL ON DEVICE, AND DIFFICULT TO POSITION/GUIDING CATHETER RESISTANCE WERE CONFIRMED. AS THE MATERIALS ON THE STENT IMPLANT ARE KNOWN MATERIALS USED DURING MANUFACTURING OF GUIDING CATHETERS, THEY LIKELY TRANSFERRED TO THE STENT IMPLANT AS A RESULT OF INTERACTIONS WITH THE GUIDING CATHETER AS RESISTANCE WAS MET. BASED ON VISUAL, DIMENSIONAL, FUNCTIONAL, AND CHEMICAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE 3.0 X 18 MM XIENCE PRIME STENT DELIVERY SYSTEM WAS ADVANCED INTO THE GUIDING CATHETER, STRONG RESISTANCE WAS MET WITH THE INNER LUMEN OF THE GUIDING CATHETER. THE SDS WAS RETRACTED AND THE STENT IMPLANT WAS FOUND TO HAVE FLARED STRUTS, AND SOME FORM OF FOREIGN MATERIAL WAS FOUND TO BE ATTACHED TO THE IMPLANT, WHICH IS BELIEVED TO BE FROM THE GUIDING CATHETER. THE SDS WAS NOT USED FOR FURTHER PROCEDURE. A NEW XIENCE PRIME STENT DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282427 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100241

    Patients

    Seq Age Sex Outcome Treatment
    1