BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6566525 · Received May 15, 2017

    Report

    Report Number
    9612164-2017-00586
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    March 26, 2015
    Report Date
    May 17, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT = DATE OF PUBLICATION JOURNAL TITLE: SUCCESSFUL DELIVERY OF POLYTETRAFLUOROETHYLENE-COVERED STENT USING RAPID EXCHANGE GUIDE EXTENSION CATHETER CARDIOVASC INTERV AND THER (2017) 32:142¿145 DOI 10.1007/S12928-016-0378-0 COMPONENT CODE: C50190. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CORONARY ANGIOGRAPHY REVEALED SUBTOTAL OCCLUSION OF THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH SEVERE CALCIFICATION, A 75 % STENOSIS IN THE MID-LEFT CIRCUMFLEX ARTERY, AND A 75 % STENOSIS IN THE MID-RIGHT CORONARY ARTERY. THE PATIENT WAS REFERRED FOR CORONARY ANGIOPLASTY TO THE LAD. RADIAL APPROACH WAS USED DURING THE PROCEDURE. THE LESION WAS PRE-DILATED. THE PHYSICIAN ATTEMPTED TO IMPLANT A 26MM RESOLUTE INTEGRITY STENT IN THE DISTAL LAD HOWEVER IT WOULD NOT ADVANCE BEYOND THE PROXIMAL LAD EVEN USING ANCHOR BALLOON TECHNIQUE. A 6F GUIDE LINER WAS INSERTED INTO THE GUIDING CATHETER AND INTRODUCED INTO THE DISTAL LAD WITHOUT DIFFICULTY. THE 26M RESOLUTE INTEGRITY STENT WAS DELIVERED AND DEPLOYED AT 18 ATMS. A 30 MM RESOLUTE INTEGRITY STENT WAS DEPLOYED AT 18 ATMS IN THE MID LAD. CORONARY ANGIOGRAPHY REVEALED MASSIVE CORONARY PERFORATION AT THE DISTAL EDGE OF THE PROXIMAL STENT. REPEATED PROLONGED BALLOON INFLATION DID NOT SEAL THE PERFORATION. AN ATTEMPT TO SEAL THE PERFORATION USING A NON-MDT STENT FAILED AS THE STENT COULD NOT CROSS THE PROXIMAL LAD DUE TO SEVERE CALCIFICATION. PERFORATION WAS FINALLY SEALED USING NON-MDT DEVICES. THE FINAL OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348131 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007050150

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention