BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 12539053 · Received September 28, 2021

    Report

    Report Number
    9612164-2021-03709
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    February 4, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ANNEX B, ANNEX C, ANNEX D CODES ADDED CORRECTION: INTERVENTION REQUIRED TICKED (B2). 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: UNCOMMON BUT IMPERATIVE CAUSE OF REPEATED ACUTE STENT THROMBOSIS: KOUNIS SYNDROME TYPE III AUTHORS: SHIRO MIURA, TAKEHIRO YAMASHITA, MASAKI MURATA, NICHOLAS G KOUNIS JOURNAL: BMJ CASE REP YEAR: 2021 REFERENCE: DOI:10.1136/BCR-2020- 240704. DATE OF EVENT: DATE OF PUBLICATION PROCEDURAL IMAGES IN THE ARTICLE SHOWED A CORONARY ARTERY ANGIOGRAPHY IN WHICH ACUTE STENT THROMBOSIS OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY FOLLOWING STENT IMPLANTATION CAN BE SEEN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CASE REPORT ENTITLED - UNCOMMON BUT IMPERATIVE CAUSE OF REPEATED ACUTE STENT THROMBOSIS: KOUNIS SYNDROME TYPE III - WAS SUBMITTED FOR REVIEW. PATIENT SUFFERED ACUTE CORONARY SYNDROME COMPLICATED BY ACUTE STENT THROMBOSIS (ST) IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) ONE HOUR AFTER A 2.5X26MM RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED UNDER THE GUIDANCE OF INTRAVASCULAR ULTRASOUND (IVUS). ONE YEAR LATER THE PATIENT PRESENTED WITH SYMPTOMS OF CHEST PAIN DURING EXERCISE. CORONARY ANGIOGRAPHY (CAG) REVEALED NO IN-STENT RESTENOSIS IN THE LAD BUT CRITICAL STENOSIS IN THE FOURTH BRANCH OF THE POSTERIOR DESCENDING ARTERY. TO TREAT THIS STENOSIS A 2.25X38MM NON-MEDTRONIC DRUG ELUTING STENT WAS IMPLANTED. PATIENT WAS PLACED ON ASPIRIN AND CLOPIDOGREL. IVUS WAS PERFORMED. ONE HOUR AFTER THE FINAL ANGIOGRAM THE PATIENT REPORTED CHEST TIGHTNESS AND NAUSEA. AN ECG REVEALED SIGNIFICANT ST-SEGMENT ELEVATION IN THE II, III AND AVF LEADS. IT WAS SUSPECTED THAT THE STEMI RESULTED FROM AN ALLERGIC REACTION AND THE KOUNIS SYNDROME TYPE III. EMERGENT CAG REVEALED THROMBOTIC SEMI-OCCLUSION OF THE PDA STENT SITE. RESIDUAL THROMBUS OVERLYING THE STENT STRUTS WAS ALSO NOTED. ASPIRATION THROMBECTOMY AND SUBSEQUENT BALLOON ANGIOPLASTY WITH A 3 MM NON-COMPLIANT BALLOON WERE PERFORMED, WHICH RESULTED IN AN IMPROVEMENT FROM THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) FLOW GRADE 1¿2. THE INTRA -AORTIC BALLOON WAS LEFT IN PLACE FOR 3 DAYS, DURING WHICH TIME THE TIMI FLOW GRADE IN THE RIGHT CORONARY ARTERY WAS 3, AS DETERMINED VIA CAG. AS CLOPIDOGREL RESISTANCE WAS SUSPECTED IT WAS REPLACED WITH PRASUGREL DURING THE BAILOUT PCI PROCEDURE. PATIENT WAS DISCHARGED FROM HOSPITAL ON DAY 12 AND HAD NO SYMPTOMS AT THE 3-MONTH FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440972 RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention