BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3121632 · Received May 21, 2013

    Report

    Report Number
    9612164-2013-00553
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 18, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY). DEFORMATION PROBLEM. EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY). INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR EVALUATION. CONCLUSIONS: DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR EVALUATION. ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. THE HYPOTUBE WAS KINKED 11.8CM DISTAL TO THE STRAIN RELIEF. A NUMBER OF THE MID STENT SEGMENTS WERE STRETCHED AND DEFORMED. THE 1ST THREE DISTAL AND FIVE PROXIMAL SEGMENTS WERE INTACT. THE FIRST THREE DISTAL SEGMENTS WERE POSITIONED OVER THE DISTAL INNER SHAFT MARKER AND BALLOON CONE. THERE WAS A GAP VISIBLE BETWEEN THE PROXIMAL PILLOW AND 1ST PROXIMAL STENT SEGMENT. NEGATIVE PURGE DID NOT DETECT A LEAK. THE BALLOON WAS INFLATED TO 9ATMS AND MAINTAINED PRESSURE. IMAGE REVIEW: THE ATTEMPTED DELIVERY OF THE ENDEAVOR RESOLUTE STENT WAS NOT CAPTURED ON THE IMAGES THAT WERE PROVIDED FOR REVIEW. THE FINAL ANGIOGRAPHIC IMAGES OF THE PROXIMAL LAD LESION APPEAR TO SHOW THAT THE LESION WAS NOT FULLY RESOLVED WITH BALLOONING AND STENTING. THEREFORE THE LESION MORPHOLOGY APPEARS TO HAVE IMPACTED ON THE SUCCESS OF THE TREATMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT AN ENDEAVOR RESOLUTE DRUG-ELUTING STENT IN A LESION WITH A ¿SEVERE GRADE OF ATHEROMATOSIS¿ AT THE THIRD MEDIUM OF ANTERIOR DESCENDING ARTERY. LESION PRE-DILATION WAS PERFORMED. RESISTANCE WAS ENCOUNTERED DELIVERING THE DEVICE THROUGH A NON-MEDTRONIC GUIDE CATHETER AND FORCE WAS REQUIRED TO BE USED TO ADVANCE THE DEVICE. THE DEVICE WAS POSITIONED, HOWEVER AFTER BALLOON INFLATION IT WAS REPORTED THAT THE STENT DID NOT POSITION CORRECTLY AT THE TARGET LESION SITE AND THE DEPLOYMENT WAS UNSUCCESSFUL. THE DEVICE WAS RETRIEVED BY PULLING IT BACK THROUGH THE GUIDE CATHETER. THE STENT WAS REPLACED WITH A NON-MEDTRONIC STENT OF THE SAME SIZE WHICH WAS SUCCESSFULLY IMPLANTED. THE ENDEAVOR RESOLUTE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. NO CLINICAL SEQUELAE WERE REPORTED. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE RX) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY RX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224942 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006088616

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR