BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1850921 · Received September 29, 2010

    Report

    Report Number
    2953200-2010-01846
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    October 23, 2009
    Report Date
    September 15, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: CVA/STROKE.

    Additional Manufacturer Narrative · 1

    PATIENT HAS A HISTORY OF PRIOR PVD. CARDIAC STATUS WAS ACUTE CORONARY SYNDROME (UNSTABLE ANGINA) AT TIME OF INDEX PROCEDURE. DURING THE INDEX PROCEDURE THREE ENDEAVOR STENT WERE IMPLANTED ONE IN THE PROX CX, ONE IN THE RAMUS AND ONE IN THE 1ST OB MAR VESSELS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY DEPLOYED A 2.5MM DIAMETER X 24MM LENGTH ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT AT CASS#12 (REF MFR# 2953200-2010-01844). TWO OTHER ENDEAVOR RX STENTS WERE IMPLANTED DURING THE SAME PROCEDURE (REF MFR# 2953200-2010-01845). REMAINING STENOSIS WAS 0%. IVUS CONFIRMED THAT THE STENTS WERE APPOSED ON THE VESSEL WALL. FOUR DAYS POST INDEX PROCEDURE, THE PT SUFFERED A CEREBRAL ISCHEMIC STROKE RESULTING IN IMPAIRMENT. IN THE INVESTIGATOR'S OPINION, THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT OR THE DRUG. AT 30 DAYS, 6 MONTH AND 9 MONTH FOLLOW-UP, CONFIRMED NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| S CLOPIDOGREL