BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 12531654 · Received September 27, 2021

    Report

    Report Number
    9612164-2021-03691
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    March 15, 2021
    Report Date
    November 24, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ANNEX B, ANNEX C, ANNEX D CODES ADDED 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 · 1

    JOURNAL ARTICLE: OPTICAL COHERENCE TOMOGRAPHY ILLUMINATES INTRAVASCULAR ULTRASOUND-INVISIBLE SAC-LIKE STRUCTURE AFTER STENT IMPLANTATION AUTHORS: SOICHI KOMAKI, MASANOBU ISHII, KAZUMASA KUROGI, NOBUYASU YAMAMOTO JOURNAL: CIRCULATION JOURNAL (JAPAN) YEAR: 2021 REFERENCE: DOI:10.1253/CIRCJ.CJ-21-0039. PROCEDURAL IMAGES WERE PROVIDED IN THE ARTICLE. THE IMAGES SHOWED THE PRE-PROCEDURAL ANGIOGRAPHY AND STENT IMPLANTATION IN THE PROXIMAL AND MID RCA. THE IMAGES ALSO SHOW THE REPORTED SLIT TRANSPARENT IMAGE AND SLOW FLOW IN THE RCA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CASE REPORT TITLED - OPTICAL COHERENCE TOMOGRAPHY ILLUMINATES INTRAVASCULAR ULTRASOUND-INVISIBLE SAC-LIKE STRUCTURE AFTER STENT IMPLANTATION - WAS SUBMITTED. CORONARY ANGIOGRAPHY (CAG) REVEALED A DIFFUSE LESION IN THE RIGHT CORONARY ARTERY (RCA). PRE-PROCEDURAL INTRAVASCULAR ULTRASOUND (IVUS) SHOWED ECCENTRIC AND FIBROFATTY PLAQUE. AFTER PREPARING THE LESION BY BALLOON ANGIOPLASTY A 4.0X26MM RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL RCA AND TWO NON-MEDTRONIC DRUG ELUTING STENTS WERE IMPLANTED IN THE MID RCA. A SLIT TRANSPARENT IMAGE BETWEEN THE STENTS WAS THEN OBSERVED ON ANGIOGRAPHY AND THE PATIENT DEVELOPED CHEST PAIN WITH ST ELEVATION IN ECG II, III AND AVF LEADS. CAG REVEALED A SLOW FLOW IN THE RCA. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS ABLE TO VISUALIZE A SAC-LIKE STRUCTURE IMPEDING BLOOD FLOW IN THE RCA. ANOTHER NON-MEDTRONIC DRUG ELUTING STENT WAS IMPLANTED TO DEFLATE THE SAC-LIKE STRUCTURE, CORONARY BLOOD FLOW IMPROVED, ECG NORMALISED AND THE CHEST PAIN DISAPPEARED. IT WAS SUGGESTED THAT THE SAC-LIKE STRUCTURE WAS CAUSED BY AN INTIMAL FLAP WHICH HAD BEEN MADE BY DISTAL EDGE DISSECTION DUE TO THE FIRST PROXIMAL STENTING MOVED PROXIMALLY AFTER WITHDRAWING THE BALLOON USED FOR DISTAL LESION PREPARATION AND STENTING. THIS PEELED VASCULAR INTIMA WAS THEN FIXED BY THE DISTAL STENTS AND INVERTED INTO THE VESSEL WHICH LIMITED THE CORONARY FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431353 RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention