BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8255125 · Received January 16, 2019

    Report

    Report Number
    2024168-2019-00391
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    December 21, 2018
    Report Date
    January 16, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199608
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EXPIRATION DATE, MANUFACTURING DATE AND MANUFACTURING SITES HAVE BEEN PROVIDED FOR BOTH STENTS: LOT #: 6051841, EXPIRATION DATE: 05/29/2019, MANUFACTURING DATE: 05/2016, MANUFACTURING SITE: (B)(4). LOT #: 8010861, EXPIRATION DATE: 01/25/2021, MANUFACTURING DATE: 01/2018, MANUFACTURING SITE: (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOTS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM EITHER LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, CONCENTRIC, MODERATELY CALCIFIED LESION IN THE HEAVILY TORTUOUS CIRCUMFLEX CORONARY ARTERY. A 4.0X12 MM XIENCE ALPINE STENT WAS BEING ADVANCED THROUGH A NON-ABBOTT GUIDE CATHETER EXTENSION AND THE STENT DISLODGED PROXIMAL TO THE TARGET LESION. WHEN THE STENT DISLODGED IT WAS PUSHED OFF THE DISTAL SIDE OF THE BALLOON. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT USING A SNARE, BUT FAILED AND THE STENT WAS ULTIMATELY DEPLOYED IN THE REGION WHERE IT DISLODGED, PARTIALLY IN THE TARGET LESION. TWO MORE XIENCE ALPINE STENTS, A 4.0X12 MM AND A 4.0X15 MM WERE SUCCESSFULLY DEPLOYED TO TREAT THE TARGET LESION AS PLANNED. THE DISLODGED STENT PARTIALLY OVERLAPPED THEM. THE PATIENT OUTCOME IS REPORTED AS RECOVERED AND DISCHARGED FROM THE HOSPITAL. REPORTEDLY, SINCE TWO 4.0X12 MM XIENCE ALPINE STENTS WERE USED DURING THE PROCEDURE (LOT 6051841 AND 8010861), THE LOT NUMBER FOR THE DISLODGED STENT COULD NOT BE IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48198 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 08717648199608

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention