BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1940140 · Received December 23, 2010

    Report

    Report Number
    2953200-2010-02654
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 25, 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
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (STENT FRACTURE, STENT DEFORMATION), (RESISTANT LESION WITH SEVERE STENOSIS AND CALCIFICATION). CONCLUSIONS: (RESISTANT LESION WITH SEVERE STENOSIS AND CALCIFICATION). CINE FILM EVALUATION: A CD OF PROCEDURAL IMAGES WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE PROCEDURE IMAGES CONFIRMED THE PRESENCE OF A NUMBER OF STENOTIC CALCIFIED LESIONS IN THE LAD. THE TARGET LESIONS WERE PRE-DILATED WITH MULTIPLE BALLOON INFLATIONS, BUT THE VESSEL PROFILE REMAINED STENOTIC AND RESISTANT TO THE BALLOONING ATTEMPTS. TWO STENTS WERE DEPLOYED TO THE MID AND PROXIMAL LAD. THE MORE DISTAL STENT, WHICH APPEARED TO BE THE 2.5 X 24MM ENDEAVOR RESOLUTE STENT, WAS DEPLOYED FIRST. THERE APPEARED TO BE A STENOTIC PORTION OF THE VESSEL AT THE LOCATION OF THE MID STENT. THE STENT APPEARED TO CONFORM TO THE LESION/VESSEL MORPHOLOGY AT THE SITE OF THE MOST CALCIFIED STENOSIS. THIS ISSUE WAS NOT RESOLVED WITH POST DILATATION OF THE STENT/VESSEL. BASED ON TWO DIMENSIONAL FLUOROSCOPIC IMAGES PROVIDED, THE STENT DID NOT APPEAR TO BE CONCENTRICALLY EXPANDED. NO IVUS IMAGING WAS PROVIDED. THE IMAGES OF THE FOLLOW UP PROCEDURE SHOWED THAT THE STENTS CONTINUED TO CONFORM TO THE LESIONS WITH NO FURTHER DEFORMITY OR DISTORTION FROM THE IMAGES TAKEN AT THE INDEX PROCEDURE. THERE WAS NO EVIDENCE OF STENT WELD OR STRUT MATERIAL BREAKAGES. IT APPEARS THAT THE FORCE APPLIED TO THE MODULAR STENT SEGMENTS DURING POST DILATATION RESULTED IN MISALIGNMENT OF THE PREVIOUSLY ADJACENT NON-WELDED STENT SEGMENTS.

    Description of Event or Problem · 1

    AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT, LENGTH 24MM, DIAMETER 2.5 MM, WAS USED TO TREAT A SEVERELY CALCIFIED AND STENOSED LAD LESION IN A PT. IT WAS REPORTED THAT THE INDEX PROCEDURE WENT SMOOTHLY AND THE STENT WAS POSITIONED CORRECTLY. IT WAS REPORTED THAT ANGIOGRAPHY WAS PERFORMED TEN DAYS POST PROCEDURE AND THE LAD STENT WAS FOUND TO BE "BROKEN". THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. IT WAS REPORTED THAT PRE-DILATATION OF THE VESSEL WAS PERFORMED. THE PT STATUS WAS REPORTED AS FINE 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 0003733209

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK