BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 20289370 · Received September 24, 2024

    Report

    Report Number
    9612164-2024-04332
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    April 16, 2024
    Report Date
    November 4, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO UNIQUE DEVICE IDENTIFIER / LOT NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED JOURNAL ARTICLE: ADVANCES IN CLINICAL CARDIOLOGY 2023: A SUMMARY OF KEY CLINICAL TRIALS AUTHORS: PATRICK SAVAGE, BRIAN COX, MICHAEL SHAHMOHAMMADI, BRONAGH KELLY, IAN MENOWN JOURNAL: ADVANCES IN THERAPY YEAR: 2024 REFERENCE: DOI: 10.1007/S12325-024-02877-Y DATE OF PUBLISH USED FOR DATE OF EVENT IN SECTION B3. THERE IS NO ESTABLISHED OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH EVENTS. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSES OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH A MEDTRONIC DEVICE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: ASPIRIN 75MG DAILY WAS CONTINUED LONG TERM. CLOPIDOGREL 75MG DAILY WAS GIVEN FOR A MINIMUM OF 6 MONTHS (OR APPROPRIATE DOSE OF PRASUGREL OR TICAGRELOR). AT 1-YEAR, THERE WAS NO DIFFERENCE BETWEEN GROUPS IN TERMS OF DEATH, MYOCARDIAL INFARCTION (MI), TARGET LESION REVASCULARIZATION (TVR), OR THE COMPOSITE OF THE THREE. STENT THROMBOSIS OCCURRED IN THE PROVISIONAL STRATEGY AND THE SYSTEMATIC TWO-STENT APPROACH GROUPS AT 1.7% AND 1.3%, RESPECTIVELY. REASONS FOR NEED FOR A SECOND STENT INCLUDED DISSECTION, RESIDUAL STENOSIS AND IMPAIRED FLOW. B7.RELEVANT HISTORY UPDATED. A2: AVERAGE AGE A3: MAJORITY GENDER MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS SUBMITTED FOR REVIEW TITLED "ADVANCES IN CLINICAL CARDIOLOGY 2023: A SUMMARY OF KEY CLINICAL TRIALS". THE AIM OF THIS ARTICLE WAS TO SUMMARISE NUMEROUS KEY CLINICAL TRIALS AND REFLECT ON THEIR CLINICAL CONTEXT. THE CLINICAL STUDY "BIFURCATION STENTING AND NEW STENT TECHNOLOGY" SUMMARY WAS REVIEWED. THE STUDY OUTLINED THAT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF BIFURCATION LESIONS CONTINUES TO BE FREQUENTLY REQUIRED IN ROUTINE PRACTICE AND CONTEMPORARY THIN STRUT STENTS MAY IMPROVE CLINICAL OUTCOMES AND FACILITATE MORE COMPLEX STENT TECHNIQUES IN COMPLEX LESIONS. THE EUROPEAN BIFURCATION CLUB LM (LEFT MAIN) CORONARY STENT (EBC MAIN) STUDY RANDOMISED 467 PATIENTS FROM FROM 11 EUROPEAN COUNTRIES WITH LEFT MAIN BIFURCATION LESIONS TO A PROVISIONAL STRATEGY VS A SYSTEMATIC TWO-STENT APPROACH USING MEDTRONIC RESOLUTE ONYX STENTS. KISSING BALLOON INFLATION AND PROXIMAL OPTIMIZATION TECHNIQUES (POT) WERE MANDATED IN BOTH ARMS ALTHOUGH THE CHOICE OF TWO-STENT TECHNIQUE WAS LEFT TO THE OPERATOR DISCRETION. AT 3 YEARS, THE COMPOSITE OF DEATH, MI AND TVR WAS SIMILAR FOR THE PROVISIONAL VS THE SYSTEMATIC TWO-STENT APPROACH (23% VS 29%; P=0.13). DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO THE RESOLUTE ONYX STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869344 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention