BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7812117 · Received August 24, 2018

    Report

    Report Number
    9612164-2018-02154
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    August 4, 2018
    Report Date
    March 25, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE LESION WAS PRE-DILATED. NO RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE TO THE LESION, AND EXCESSIVE FORCE WAS NOT USED. THE STENT DID NOT DISPLACE FROM ITS ORIGINAL POSITION. THE DELIVERY SYSTEM CATHETER WAS BENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: PHOTO 1; IMAGE SHOWS THE DISTAL PORTION OF A STENT DELIVERY SYSTEM AND A PORTION OF RESOLUTE INTEGRITY SHELF CARTON. DEFORMATION IS EVIDENT TO THE DISTAL STENT WRAPS WITH THE STRUTS APPEARING RAISED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS SUMMARY: STENT WAS POSITIONED BETWEEN THE MARKERBANDS BUT NOT MEETING SPECIFICATIONS DUE TO DEFORMATION OF THE DISTAL STENT STRUT. DEFORMATION WAS EVIDENT TO THE 1ST DISTAL STENT WRAP. THE STRUT HAD FRACTURED AND WAS RAISED AND STRETCHED. THE DEVICE WAS SENT FOR SEM TESTING AND IT WAS CONFIRMED THAT THE WIRE HAD BECOME DETACHED FROM THE REST OF THE STENT AND THE DETACHMENT SITE WAS ADJACENT TO THE SECOND WELD ON THE STENT. THE SECOND WELD WAS INTACT AND HAD NOT BEEN COMPROMISED. RESULTS OF SEM TESTING CONFIRMED THAT BASED ON THE SEM¿S OF THE RECREATED FRACTURE, IT CAN BE CONCLUDED THAT THE COMPLAINT PIECE IN (B)(4) DID NOT FRACTURE PRE-ANNEAL OR HAVE ANY EXISTING CRACKS PRE-ANNEAL. NO MANUFACTURING DEFECTS WERE NOTED ON THE COMPLAINT SEM WHICH COULD HAVE INITIATED THE FRACTURE. THE PRESENCE OF A LARGE RADIAL ZONE IN THE COMPLAINT PIECE INDICATES THAT A LARGE TEARING FORCE GREATER THAN WHAT THE STENT WAS DESIGNED TO WITHSTAND WAS APPLIED TO THE STENT WHICH RESULTED IN THE FRACTURE. NO DEFORMATION WAS EVIDENT TO THE DISTAL TIP. DEFORMATION WAS EVIDENT TO THE DISTAL SHAFT. THE INNER LUMEN PATENCY WAS VERIFIED WITH A 0.015 INCH MANDREL. NO OTHER DAMAGE EVIDENT TO THE REMAINDER OF THE DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. ABNORMALITIES WERE REPORTED IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS OBSERVED THAT ON REMOVAL OF THE DEVICE A SMALL SECTION OF THE STENT HAD DEFORMED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656035 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008786389

    Patients

    Seq Age Sex Outcome Treatment
    1