BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2822549 · Received November 7, 2012

    Report

    Report Number
    2024168-2012-07004
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 16, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DAMAGE WAS ABLE TO BE CONFIRMED; HOWEVER, THE STENT WAS NOT FRACTURED AS REPORTED. THE FAILURE TO ADVANCE AND DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE XIENCE PRIME, XIENCE PRIME SMALL VESSEL AND XIENCE PRIME LONG LENGTH EVEROLIMUS ELUTING STENT SYSTEM INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: RUNTHROUGH FLOPPY. GUIDE CATHETER: XB 3.5 7F. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY TORTUOSITY AND MODERATE CALCIFICATION, PRE-DILATATION WAS PERFORMED WITH A 2.5X15 TREK BALLOON CATHETER. A 2.5X15 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS THE LESION. REPORTEDLY, THE PHYSICIAN TRIED TO PUSH THE SDS BUT NOTED IT WAS STUCK. THE 2.5X15 RX XIENCE PRIME SDS WAS WITHDRAWN FROM THE PATIENT WITH RESISTANCE AND THE END OF THE STENT BECAME FLARED AND FRACTURED; HOWEVER, IT REMAINED ON THE BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032241

    Patients

    Seq Age Sex Outcome Treatment
    1