BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8240137 · Received January 11, 2019

    Report

    Report Number
    2024168-2019-00285
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    November 7, 2018
    Report Date
    February 8, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER: (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THE STENT INTERACTED WITH THE GUIDE WIRE DURING REMOVAL OF THE GUIDE WIRE CAUSING THE REPORTED DEVICE DAMAGED BY ANOTHER (JAILED GUIDE WIRE). THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: THE CORRECT SIZE OF XIENCE SIERRA STENT USED IN THIS CASE WAS A 2.5X23MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). USER FACILITY MEDWATCH RECEIVED STATES: PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FROM URGENT CARE CENTER WITH C/O CHEST PAIN AND KNOWN ST ELEVATIONS IN LEADS II, III AND AVF WITH DEEP ST DEPRESSION IN LEADS V1-V3. PATIENT TAKEN EMERGENTLY TO CARDIAC CATH LAB FOR PERCUTANEOUS INTERVENTION. EMERGENT CORONARY ANGIOGRAPHY SHOWED AN OCCLUDED RAMUS INTERMEDIUS VESSEL WHICH BIFURCATED INTO TWO LARGE BRANCHES. A 6F EBU 3.25 GUIDE CATHETER WAS USED TO ENGAGE THE LEFT MAIN TRUNK (LMT) OSTIUM, A BALANCED MIDDLE WEIGHT (BMW), LOT #8060871 REF #(B)(4), WAS NAVIGATED INTO THE DISTAL RAMUS. THE OCCLUDED SEGMENT OF THE ARTERY WAS DILATED WITH 2.0X12 MM MINI TREK BALLOON. AS THE WIRE WAS INSERTED INTO THE LARGER INFERIOR BRANCH WITH THE INTENT OF STENTING OVER THE WIRE DIRECTED INTO THE INFERIOR BRANCH. THE RAMUS WAS STENTED WITH A 2.5X2 MM XIENCE SIERRA DES AND FLOW RESTORED. FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI), THE CORONARY WIRES WERE REMOVED. ON PULLING BACK, THE JAILED SUPERIOR BMW WIRE RESISTANCE WAS ENCOUNTERED AND THE TIP OF THE WIRE WAS RETAINED IN THE STENT STRUTS. FOLLOWING PCI, THE PATIENT WAS CHEST PAIN FREE AND REMAINED HEMODYNAMICALLY STABLE. THE PATIENT WAS TRANSFERRED TO A TERTIARY CENTER FOR MANAGEMENT AND POTENTIAL TREATMENT OF THE RETAINED WIRE. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE BMW UNIVERSAL GUIDE WIRE IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT #. MEDWATCH REPORT NUMBER (B)(4) . (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE 100% STENOSED, PROXIMAL RAMUS CORONARY ARTERY, TWO BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRES WERE PLACED, ONE OF WHICH WAS IN A SIDE BRANCH. AN UNSPECIFIED STENT WAS DEPLOYED ACROSS THE BMW UNIVERSAL GUIDE WIRE, JAILING THE WIRE IN THE SIDE BRANCH. AFTER POST-DILATATION WAS PERFORMED, AN ATTEMPT WAS MADE TO REMOVE THE BMW UNIVERSAL GUIDE WIRE, BUT THE GUIDE WIRE WAS STUCK AND THE TIP OF THE GUIDE WIRE HAD UNRAVELED. THE CORE OF THE BMW UNIVERSAL GUIDE WIRE SEPARATED LEAVING A PORTION IN THE LEFT MAIN ALL THE WAY BACK TO THE AORTA TO THE SUBCLAVIAN. THE PROXIMAL REMAINING PORTION OF THE GUIDE WIRE WAS REMOVED. NO ATTEMPTS TO RETRIEVE THE SEPARATED PORTION OF THE GUIDE WIRE WERE ATTEMPTED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AS THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL CENTER. NO INTERVENTION WAS PERFORMED TO REMOVE THE SEPARATED PORTION OF THE GUIDE WIRE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION ON DUAL-ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33724 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR GUIDE WIRE: BMW UNIVERSALGUIDE CATH: 6F EBU 3.25| GUIDE WIRE: BMW UNIVERSALGUIDE CATH: 6F EBU 3.25