BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6817130 · Received August 24, 2017

    Report

    Report Number
    2024168-2017-06913
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 28, 2017
    Report Date
    December 1, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER UPDATED FROM 5033141 TO 5042341. PART SEQUENCE TWO, UNK GUIDE WIRE, WAS REPLACED WITH PART SEQUENCE THREE, UNK PROWATER. THE GUIDE WIRE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER AS (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED STENT BREAK WAS UNABLE TO BE CONFIRMED HOWEVER THERE WAS NOTED STENT DAMAGE (FLARED). THE REPORTED DIFFICULTY TO POSITION AND THE REPORTED DIFFICULTY TO REMOVE USING A GUIDE WIRE WERE ABLE TO BE CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE FROM THE VESSEL WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.5X33MM XIENCE ALPINE OTW DRUG-ELUTING STENT (DES) SYSTEM WAS ADVANCED OVER AN UNSPECIFIED GUIDE WIRE WITHOUT DIFFICULTY FOR TREATMENT OF AN UNSPECIFIED VESSEL. WHEN PULLING THE ALPINE SYSTEM BACK TO POSITION THE STENT, IT BECAME STUCK ON THE GUIDE WIRE. THE STENT WAS ALSO DIFFICULT TO RETRACT FROM THE LESION. BOTH THE XIENCE ALPINE OTW DES SYSTEM AND GUIDE WIRE WERE WITHDRAWN AS A SINGLE UNIT THROUGH THE GUIDING CATHETER WITHOUT FURTHER REPORTED ISSUE WHEN A STENT STRUT WAS NOTED TO BE FRACTURED. NO OTHER DAMAGE WAS NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. THE TARGET LESION WAS TREATED VIA DEPLOYMENT OF AN UNSPECIFIED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599093 XIENCE ALPINE OTW EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5042341

    Patients

    Seq Age Sex Outcome Treatment
    1