BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 8586631 · Received May 7, 2019

    Report

    Report Number
    9612164-2019-01604
    Event Type
    Injury
    Date Received
    May 7, 2019
    Date of Event
    April 1, 2008
    Report Date
    May 7, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    "FRACTURE OF ZOTAROLIMUS-ELUTING STENT AFTER IMPLANTATION." TEX HEART INST J 2009; 36 (6): 618-20. STILL PROCEDURAL IMAGE REVIEW- CINEANGIOGRAPHY REVEALS A GRADE IV FRACTURE IN THE ENDEAVOR STENT. CORONARY ANGIOGRAPHY REVEALS IN-STENT RESTENOSIS AT A BIFURCATION OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. IMPLANT DATE: MONTH AND YEAR VALID. DATE OF EVENT: MONTH AND YEAR VALID. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RX ZOTAROLIMUS ELUTING STENT WAS USED TO TREAT A BIFURCATED LAD LESION. THE LESION WAS PRE-DILATED WITH A SPRINTER RX BALLOON CATHETER AT 8ATM. THE ENDEAVOR SPRINT STENT WAS DEPLOYED AT 12ATM. THE OSTIAL STENOSIS OF THE DIAGONAL BRANCH WAS DILATED AGAIN WITH A SPRINTER BALLOON WITH GOOD RESULTS REPORTED. APPROXIMATELY 10 MONTHS LATER THE PATIENT AGAIN EXPERIENCED ANGINA. ANGIO REVEALED STENT FRACTURE GRADE IV THAT WAS ASSOCIATED WITH IN-STENT RESTENOSIS. KISSING BALLOON TECHNIQUE WAS USED TO TREAT THE BIFURCATION USING TWO SPRINTER BALLOONS. IT WAS REPORTED THAT THE PATIENTS CLINICAL SYMPTOMS IMPROVED AND REMAINED STABLE ON FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380863 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention