BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 3575805 · Received January 15, 2014

    Report

    Report Number
    9612164-2014-00020
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    January 1, 2013
    Report Date
    December 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE ¿ (PERFORATION); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿ SEVERE STENOSIS. (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW ¿ DEVICE NOT RETURNED FOR EVALUATION; (RELATED TO OPERATIONAL CONTEXT) - EXCESSIVE PRESSURE IN THE STENT MOUNTED BALLOON (16ATM) WAS ONE OF THE REASONS FOR THE PERFORATION. CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ SEVERE STENOSIS. INHERENT RISK OF PROCEDURE ¿ (PERFORATION); (RELATED TO OPERATIONAL CONTEXT) - EXCESSIVE PRESSURE IN THE STENT MOUNTED BALLOON (16ATM) WAS ONE OF THE REASONS FOR THE PERFORATION. (B)(4). OPTICAL COHERENCE TOMOGRAPHIC AND ANGIOSCOPIC ASSESSMENTS OF ARTERIAL HEALING IN CORONARY ARTERY PERFORATION AFTER IMPLANTATION OF ZOTAROLIMUS-ELUTING STENT INTERNATIONAL HEART JOURNAL INT HEART J 2013; 54: 332- ISSUE 54. DATE OF EVENT = PUBLICATION DATE (YEAR ONLY VALID).

    Description of Event or Problem · 1

    PHYSICIAN IMPLANTED 1 ENDEAVOR DRUG-ELUTING STENT TO A LESION IN THE LCX WITH SEVERE STENOSIS, TO A MAXIMAL PRESSURE OF 16 ATM. A PERFORATION WAS NOTED AND TREATED WITH A STENT DELIVERY BALLOON BEING INFLATED AT 8ATM¿S 3 TIMES FOR 10 MINUTES. THE PERFORATION SITE WAS SEALED. IT WAS REPORTED THAT EXCESSIVE PRESSURE IN THE STENT MOUNTED BALLOON (16ATM) WAS ONE OF THE REASONS FOR THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40269 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention CLOPIDOGREL AND ASPIRIN.