BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4242325 · Received November 11, 2014

    Report

    Report Number
    9612164-2014-01451
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    January 6, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DEFORMATION PROBLEM.

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-70% STENOSIS. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. NO DEVICE RETURNED. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION-70% STENOSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION: FAILURE TO FOLLOW INSTRUCTIONS (LESION WAS NOT PRE-DIALTED). (B)(4)

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. THERE WERE NUMEROUS KINKS VISIBLE ALONG THE HYPOTUBE. THE 18TH, 19TH, 20TH, 25TH AND 26TH PROXIMAL STENT SEGMENTS WERE DEFORMED WITH NUMEROUS STRUTS PARTIALLY RAISED. THE REMAINING SEGMENTS WERE INTACT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION IN THE LAD. THE LESION EXHIBITED 70% STENOSIS, MODERATE TORTUOSITY AND MODERATE CALCIFICATION. DURING THE DELIVERY THE STENT GOT STUCK BY THE LESION AND THE PHYSICIAN SAW THAT THERE A KINK IN THE STENT, THEREFORE THE STENT COULD NOT PASS THROUGH THE LESION. THE STENT WAS WITHDRAWN. NO CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE LESION WAS NOT PRE-DILATED. NO ABNORMALITY WAS NOTED DURING PREPARATION OR INSPECTION OF THE RESOLUTE DEVICE PRIOR TO USE. NO RESISTANCE NOTED BETWEEN THE RESOLUTE AND OTHER DEVICES USED IN THE PROCEDURE OR DURING DELIVERY TO LESION. DURING THE DELIVERY THE STENT GOT STUCK AT ONE OF THE VESSEL CURVES. THE STENT WAS WITHDRAWN WITH SOME DIFFICULTY. ANOTHER SAME SIZE RESOLUTE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726608 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006847728

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR