BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 23189521 · Received October 1, 2025

    Report

    Report Number
    9612164-2025-04838
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    July 15, 2025
    Report Date
    November 4, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ANNEX D CODE. 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

    SALVATORE COLANGELO, RICCARDO MANGIONE, MARIO IANNACCONE, FRANCESCO COLOMBO, GIACOMO GIOVANNI BOCCUZZI "INTERACTION BETWEEN GUIDING-EXTENSION CATHETER AND DRUG-ELUTING STENTS: ALWAYS SAFE OR SOMETIMES HARMFUL?" CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2025; 1¿4 HTTPS://DOI.ORG/10.1002/CCD.70035 A2: AVERAGE AGE A4: AVERAGE WEIGHT B3: DATE OF PUBLICATION THERE IS NO ESTABLISHED OR SUSPECTED CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH EVENTS. DEATHS ARE COMMON OCCURRENCES IN CLINICAL STUDIES, HOWEVER THE CAUSE(S) 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. NO UNIQUE DEVICE IDENTIFIER (LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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 "INTERACTION BETWEEN GUIDING-EXTENSION CATHETER AND DRUG-ELUTING STENTS: ALWAYS SAFE OR SOMETIMES HARMFUL?". THE AIM OF THIS STUDY WAS TO COMPARE THE PERFORMANCES OF A NON MEDTRONIC POLYMER-FREE DRUG ELUTING STENT (DES) WITH ALL THE OTHER SURFACE- COATED DES TO INVESTIGATE IF THE ABLUMINAL GROOVES OF THIS POLYMER-FREE DES, WHICH CONTAIN THE DRUG AND AVOID ANY RISK OF ITS ABRASION AND DETACHMENT (ABLUMINAL RESERVOIR TECHNOLOGY), MAY OFFER A PROTECTIVE EFFECT DURING STENT ADVANCEMENT WITHIN THE GUIDE EXTENSION CATHETER (GEC). BETWEEN JANUARY 2019 AND APRIL 2024, 218 PATIENTS WHO UNDERWENT COMPLEX PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURES WITH THE INSERTION OF A DES AND THE USE OF GEC WERE ENROLLED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO GROUP A (39 PATIENTS) WHO RECEIVED THE NON-MEDTRONIC POLYMER-FREE DES, WHILE GROUP B (179 PATIENTS) RECEIVED OTHER TYPES OF DES. STENTS USED IN GROUP B INCLUDED THE MEDTRONIC STENTS, RESOLUTE ONYX (N=62) AND ONYX FRONTIER (N=38) AS WELL AS SEVERAL NON-MEDTRONIC BRANDS OF STENT. LESIONS TREATED INCLUDED THE LEFT ANTERIOR DESCENDING ARTERY (LAD), LEFT CIRCUMFLEX ARTERY (LCX), RIGHT CORONARY ARTERY (RCA), LEFT MAIN (LM) AND THE SAPHENOUS VEIN GRAFT (SVG). THE GECS USED DURING THESE PCIS WERE AMONG TWO NON-MEDTRONIC BRANDS, SPECIFICALLY A 5-5.5-6F NON-MEDTRONIC GEC AND A 6F NON-MEDTRONIC GEC. THE STUDY'S PRIMARY ENDPOINT WAS TO EVALUATE THE EFFICACY AND SAFETY OF THE DEVICES BEING INVESTIGATED AS WELL AS TO DEFINE THE TARGET LESION FAILURE ASSOCIATED WITH THE TREATMENTS USED. TO ADDRESS THESE OBJECTIVES, A DEVICE-ORIENTED COMPOSITE ENDPOINT (DOCE) WAS ASSESSED AT 1-YEAR OF FOLLOW-UP. THIS ENDPOINT INCLUDED CARDIOVASCULAR DEATH, TARGET VESSEL MYOCARDIAL INFARCTION, AND CLINICALLY AND PHYSIOLOGICALLY INDICATED TARGET LESION REVASCULARIZATION. AT 1 YEAR, THE EVENT-FREE SURVIVAL FROM DOCE WAS 97.4% IN GROUP A AND 85.5% IN GROUP B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105644 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention