BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 15223900 · Received August 15, 2022

    Report

    Report Number
    9612164-2022-03053
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    January 26, 2022
    Report Date
    October 17, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AUTHORS:YOSHINOBU MURASATO, YUSUKE WATANABE, MASAHIRO YAMAWAKI , YOSHIHISA KINOSHITA, MUNENORI OKUBO, KAZUHIKO YUMOTO, NAOKI MASUDA JOURNAL NAME:CATHETER CARDIOVASC INTERV YEAR: 2022 TITLE OF ARTICLE: EFFECT OF PROXIMAL OPTIMIZATION TECHNIQUE ON CORONARY BIFURCATION STENT FAILURE: INSIGHTS FROM THE MULTICENTER RANDOMIZED PROPOT TRIAL LITERATURE REFERENCE: DOI: 10.1002/CCD.30120 A2=AVERAGE AGE A3= MAJORITY GENDER B3=DATE OF PUBLICATION MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE TITLED - EFFECT OF PROXIMAL OPTIMIZATION TECHNIQUE ON CORONARY BIFURCATION STENT FAILURE: INSIGHTS FROM THE MULTICENTER RANDOMIZED PROPOT TRIAL - WAS SUBMITTED FOR REVIEW. THE AIM OF THIS PROSPECTIVE OPEN-LABEL RANDOMIZED STUDY WAS TO INVESTIGATED THE EFFECT OF PROXIMAL OPTIMIZATION TECHNIQUE (POT) ON C ORONARY BIFURCATION STENT FAILURE (BSF) IN CROSS-OVER STENTING BY COMPARING WITH THE KISSING BALLOON TECHNIQUE (KBT) IN A MULTICENTER RANDOMIZED PROPOT TRIAL. THE PRIMARY ENDPOINTS WERE COMPOSITE BSF BEFORE SIDE BRANCH DILATION (SBD) AND AT THE FINAL PROCEDURE, AND THE ADDITIONAL PROCEDURE FOR THE CORRECTION OF HIGH-RISK STENT FAILURE, IF APPLICABLE. THE SECONDARY ENDPOINTS WERE THE RISK FACTORS FOR EACH BSF. MEDTRONIC RESOLUTE INTEGRITY AND RESOLUTE ONYX CORONARY ZOTAROLIMUS-ELUTING STENTS WERE IMPLANTED IN ALL CORONARY BIFURCATION LESIONS. A TOTAL OF 120 PATIENTS FROM 15 INSTITUTES WERE ENROLLED IN THE STUDY. AFTER EXCLUSION, THE DATA OF 109 PATIENTS (POT GROUP: 52 P ATIENTS; KBT GROUP: 57 PATIENTS) WAS ANALYZED. OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGING WAS PERFORMED BEFORE THE SBD AND AT THE END OF THE PROCEDURE. TO AVOID FATAL ADVERSE EVENTS, ADDITIONAL TREATMENT PROCEDURES, INCLUDING RE-POT OR ADDITIONAL KBT, WERE ALLOWED ONLY AFTER SBD OR KBT IN CASES OF HIGH-RISK STENTFAILURE WITH A STENT MALAPPOSITION OF >400 ¿M FROM THE VESSEL WALL IN ANY PART OF THE STENT, OR SERIOUS LUMEN NARROWING OF THE STENT AREA. THE INCIDENCE OF COMPOSITE BSF BEFORE SBD WAS NOT DIFFERENT BETWEEN THE TWO GROUPS. BEFORE SBD, THE MAXIMUM MALAPPOSITION DISTANCE AND THE RATES OF MALAPPOSITION AND SB-JAILED STRUTS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE POT AND KBT GROUPS. THE FREQUENCY OF ADDITIONAL PROCEDURES FOR HIGH-RISK STENT FAILURE WAS NUMERICALLY HIGHER IN THE POT GROUP THAN IN THE KBT GROUP. THIS MIGHT BE RELATED TO INCREASED RISKS OF MAIN BRANCH OSTIAL NARROWING, STENT DEFORMATION AT THE SB-OPPOSITE SIDE AND WORSENING OF MALAPPOSITION. ADDITIONAL PROCEDURES WERE ONLY ALLOWED IN CASES OF SIGNIFICANT STENT MALAPPOSITION OR DISTAL MAIN VESSEL (MV) OSTIAL NARROWING, AFTER COMPLETION OF STUDY PROTOCOL. THERE WAS THREE CASES WITH ADVERSE CARDIAC EVENTS (TWO CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION AND ONE MYOCARDIAL INFARCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295171 RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male