BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1824794 · Received September 1, 2010

    Report

    Report Number
    2024168-2010-01809
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFORMATION. DEVICE #1 - XIENCE V 2.75X18 (PART #1009539-18; LOT #0032641), REFERENCE IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE #2 ISSUE: DISLODGED STENT. TIME OF DEVICE ISSUES: DURING STENTING PROCEDURE. ADVERSE EVENT: SNARED DISLODGED STENT AND EXPLANTED FIRST STENT. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE THE 2.75X08 RX XIENCE V STENT WAS SUCCESSFULLY DEPLOYED IN THE OSTIUM OF THE LEFT CIRCUMFLEX ARTERY (LCX). THE 2.75X18 RX XIENCE V STENT FAILED TO ADVANCE TO THE MID LEFT ANTERIOR DESCENDING (LAD) BECAUSE OF CALCIFICATION. THE PHYSICIAN FELT THAT POSSIBLY PRE-DILATATION WAS INSUFFICIENT. THERE WAS DIFFICULTY REMOVING THE 2.75X18 RX XIENCE V AND ONCE THE DEVICE WAS REMOVED IT WAS FOUND THAT THE STENT HAD DISLODGED. AN ANGIOGRAM WAS TAKEN AND FOUND THE STENT HAD DISLODGED AT THE OSTIUM OF THE LAD AND HAD EMBOLIZED. A SNARE DEVICE WAS USED TO REMOVE THE DISLODGED STENT. ONCE OUTSIDE THE ANATOMY IT WAS FOUND THAT THE DISLODGED 2.75X18 STENT AND THE 2.75X08 STENT WERE ENTANGLED AND REMOVED TOGETHER. ANOTHER TWO RX XIENCE V STENTS WERE SUCCESSFULLY DEPLOYED, ONE IN THE OSTIUM OF THE LCX AND ONE MID LAD. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THE FOLLOWING DAY THE PATIENT RETURNED TO HAVE THE RIGHT CORONARY ARTERY STENTED AND THE PHYSICIAN TOOK PICTURES OF THE LEFT CORONARY ARTERY CHECKING ON THE TWO RX XIENCE V STENTS AND EVERYTHING LOOKED FINE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 8111441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (PART #1009539-18, LOT #0032641)| STENT: DEVICE #1 - XIENCE V 2.75X18