BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3143037 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03456
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. THE REPORTED RESISTANCE WITH THE OTHER SDS COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON THE VISUAL 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. A 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: PROWATER, RUNTHROUGH; GUIDE CATHETER: 6FXBLAD 3.5; STENT DELIVERY SYSTEM: XIENCE XPEDITION 3.00 X18. THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER XIENCE XPEDITION DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE 3.0X18 STENT DELIVERY SYSTEM WAS DEFLATED FOR APPROXIMATELY SEVEN TO EIGHT SECONDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROWATER GUIDEWIRE WAS ADVANCED TO TARGET LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) AND THE RUNTHROUGH GUIDEWIRE WAS ADVANCED TO THE TARGET LESION IN THE FIRST DIAGONAL ARTERY (D1) THROUGH THE 6FXBLAD 3.5 GUIDE CATHETER. THE 3.0X18 XIENCE XPEDITION WAS SUCCESSFULLY DEPLOYED IN THE MID LAD, BUT THE STENT DELIVERY SYSTEM (SDS) WAS NOT REMOVED FROM THE GUIDE CATHETER. WITH THE FIRST SDS (3.0X18) IN THE GUIDE CATHETER, THE SECOND XIENCE XPEDITION (2.5X18) SDS WAS ADVANCED THROUGH THE SAME GUIDE CATHETER AND ENCOUNTERED RESISTANCE WITH THE FIRST SDS (3.0X18). THE FIRST SDS (3.0X18) WAS REMOVED, BUT ENCOUNTERED RESISTANCE AND FORCE WAS APPLIED TO TRY TO REMOVE THE 3.0X18 SDS. THE DISTAL SHAFT OF THE 3.0X18 SDS SEPARATED AND REMAINED IN THE GUIDE CATHETER. THE 2.5X18 STENT DISLODGED FROM THE SECOND SDS. BOTH SDS, THE DISLODGED STENT (2.5X18), THE TWO GUIDEWIRES, AND THE GUIDE CATHETER WERE REMOVED TOGETHER AS A SINGLE UNIT. THE SEPARATED SEGMENT OF THE SHAFT AND THE DISLODGED 2.5X18 STENT WERE REMOVED WITH THE GUIDE CATHETER. A SECOND 6FXBLAD 3.5 GUIDE CATHETER WAS ADVANCED AND ANOTHER 2.5X18 XIENCE XPEDITION SDS WAS SUCCESSFULLY DEPLOYED IN THE D1. THERE WERE NO ISSUES WITH THE GUIDEWIRES. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244691 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2120641

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR