BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1823606 · Received August 27, 2010

    Report

    Report Number
    2953200-2010-01641
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (FAILURE TO DELIVER STENT, STENT DEFORMATION); (DIFFUSE DISEASE). CONCLUSIONS: (DIFFUSE DISEASE). EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECIFICATION. A NUMBER OF STRUTS ON THE 8TH PROXIMAL STENT SEGMENT WERE RAISED AND PULLED DISTALLY. A NUMBER OF STRUTS ON THE 15TH PROXIMAL SEGMENT WERE SLIGHTLY DEFORMED. A NUMBER OF STRUTS ON THE 9TH DISTAL SEGMENT WERE DEFORMED AND SLIGHTLY RAISED. THERE WAS DAMAGE TO THE DISTAL TIP. A CD OF PROCEDURAL IMAGES WAS ALSO RETURNED FOR EVALUATION. CD IMAGES SHOWED EVIDENCE OF DIFFUSE DISEASE PRESENT IN THE VESSEL FOLLOWING NUMEROUS PRE-DILATIONS. THE CD IMAGES SHOWED THAT THE VESSEL WAS DOUBLE WIRED AND THERE WERE IMAGES OF A TUBE OR SHEATH IN THE PROXIMAL PORTION OF THE VESSEL. IMAGES SHOWED THE SUCCESSFUL DEPLOYMENT OF A LONG STENT IN THE DISTAL PORTION OF THE LESION.

    Description of Event or Problem · 1

    AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT, LENGTH 30MM, DIAMETER 2.5 MM, WAS INTENDED TO TREAT A 80% STENOSED RCA, LESION IN A PATIENT. IT WAS REPORTED THAT THE DEVICE DID NOT PASS THE LESION, AND ON REMOVAL FROM THE PATIENT, THE STENT STRUTS WERE DEFORMED. THE LESION WAS PRE-DILATED WITH A 2.5 X 12MM BALLOON PRIOR TO 12 ATM, 2 INFLATIONS, PRIOR TO ATTEMPTED STENT PLACEMENT. ANOTHER RESOLUTE STENT, LENGTH 30MM, DIAMETER 2.25 MM, (REF MFR REPORT # 2953200-2010-01640) FAILED TO CROSS THE LESION EARLIER IN THE SAME PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. RESISTANCE WAS FELT WHILE ATTEMPTING TO ADVANCE THE DEVICE ACROSS THE LESION AND DURING REMOVAL OF THE DEVICE. TWO FURTHER RESOLUTE STENTS WERE USED TO SUCCESSFULLY TREAT THE VESSEL. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001928308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK