BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1670977 · Received April 28, 2010

    Report

    Report Number
    2953200-2010-00737
    Event Type
    Death
    Date Received
    April 28, 2010
    Date of Event
    December 22, 2009
    Report Date
    November 7, 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: (ECCENTRIC, TORTUOUS LESION WITH CALCIFICATION), (PERFORATION). CONCLUSION: (ECCENTRIC, TORTUOUS LESION WITH CALCIFICATION).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A 2.25MM DIAMETER X 30MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN TO A PATIENT TO TREAT A LESION LOCATED IN THE LAD # 7 DESCRIBED AS A TORTUOUS, ECCENTRIC WITH CALCIFICATION. DURING PROCEDURE, A MICRO DRIVER RX CORONARY STENT WAS DEPLOYED AT LAD # 8 (MFR REPORT 2953200-2010-00736) AND ANOTHER MANUFACTURER'S STENT WAS DEPLOYED AT LAD # 6. COMMUNICATION FROM THE FIELD CONFIRMED THAT, DUE TO THE LESION MORPHOLOGY, DIFFICULTIES WERE ENCOUNTERED ADVANCING THE RELEVANT DEVICE WHICH WAS SCREWED IN THE VESSEL USING AND INNER CATHETER AND APPLYING SOME FORCE. HOWEVER, IT WAS REPORTED THAT RUPTURE OF THE CORONARY ARTERY WAS OBSERVED WHERE THE RELEVANT STENT WAS DEPLOYED. THREE UNITS OF COVERED STENTS WERE IMPLANTED TO TREAT THE VESSEL PERFORATION. THE PHYSICIAN COMMENTED THAT THERE SEEMS TO BE NO RELATIONSHIP BETWEEN THE OCCURRENCE OF PERFORATION AND THE RELEVANT DEVICE. THE PATIENT IS REPORTED TO BE FINE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    PATIENT HAD MYELODYSPLASTIC SYNDROME (MDS) BEFORE STENT IMPLANT, ANEMIA WAS ADVANCED AND MDS WAS SUSPECTED TO HAVE ADVANCED TO LEUKEMIA. PATIENT WAS FREE FROM AE AT 30 DAY, 6, 9 AND 12 MONTH FOLLOW UP. APPROXIMATELY 14 MONTHS 2 WEEKS POST INDEX PROCEDURE PATIENT EXPIRED DUE TO MYELOMONOCYTIC LEUKEMIA. REF MFR # 2953200-2010-00736, 2953200-2010-00737.

    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 0001055164

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| R