BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 23094008 · Received September 19, 2025

    Report

    Report Number
    9612164-2025-04651
    Event Type
    Death
    Date Received
    September 19, 2025
    Date of Event
    January 29, 2025
    Report Date
    November 24, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARNAUD PLANCHAT, YAZAN MUSAYEB, FRÉDÉRIC GLAUSER, JUAN F. IGLESIAS, MARCO ROFFI. 'A NOVEL UTILIZATION OF A PERIPHERAL SELF-EXPANDING NITINOL STENT TO TREAT RECURRENT CORONARY STENT FRACTURE.' CORONARY, PERIPHERAL, AND STRUCTURAL INTERVENTIONS, 2025 HTTPS://DOI.ORG/10.1016/J.JACCAS.2025.10 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    ADDITIONAL INFORMATION: ANNEX D CODE. CORRECTION: ANNEX E AND F CODES. WHEN THE PATIENT INITIALLY PRESENTED WITH STABLE ANGINA, A NON-MEDTRONIC 3.5 X 24MM CORONARY STENT WAS IMPLANTED AND POST-DILATED WITH A 3.5-MM NON-COMPLIANT (NC) BALLOON AT 18 ATM. THE 4.0 × 40MM NON-MEDTRONIC SIROLIMUS-ELUTING BALLOON WAS INFLATED TO A MAXIMUM PRESSURE OF 6 ATM FOR 180 SECONDS. DOI: HTTPS://DOI.ORG/10.1016/J.JACCAS.2025.103423. 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 CASE STUDY WAS SUBMITTED FOR REVIEW TITLED 'A NOVEL UTILIZATION OF A PERIPHERAL SELF-EXPANDING NITINOL STENT TO TREAT RECURRENT CORONARY STENT FRACTURE.' THIS CASE PRESENTS THE NOVEL USE OF A PERIPHERAL SELF-EXPANDING NITINOL STENT TO TREAT RECURRENT CORONARY STENT FRACTURES (SFS) IN A SAPHENOUS VEIN GRAFT (SVG) PREVIOUSLY TREATED WITH 2 LAYERS OF DRUG-ELUTING STENTS. THE PATIENT PRESENTED WITH STABLE ANGINA OWING TO AN ISOLATED SUBTOTAL LESION OF THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA), WITH NO EVIDENCE OF DISEASE ELSEWHERE IN THE GRAFT. THE LESION WAS LOCATED CLOSE TO THE AORTIC ANASTOMOSIS AND WAS TREATED SUCCESSFULLY WITH A CORONARY STENT IMPLANTATION. FIVE MONTHS LATER, THE PATIENT DEVELOPED STABLE ANGINA IN THE PRESENCE OF A SUBTOTAL IN-STENT RESTENOSIS OF THE SVG OWING TO STENT FRACTURE (SF). THE SF WAS CONSIDERED TO BE THE RESULT OF SHEAR MECHANICAL FORCES BETWEEN THE SVG AND THE ASCENDING AORTA IN ADDITION TO THE EXTRINSIC COMPRESSION OF A CALCIFIED PLAQUE DOCUMENTED BY INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION. AFTER RECANALIZATION AND BALLOON INTRASTENT DILATATION, A THROMBOSE IN THE MID DISTAL PORTION OF THE SVG WAS OBSERVED. PCI WITH IMPLANTATION OF A 4.0X38.0MM RESOLUTE ONYX RX ZOTAROLIMUS-ELUTING STENT POST-DILATED WITH A 4.0-MM NC BALLOON AT 14 ATM WAS PERFORMED AT THE LEVEL OF THE FRACTURED STENT IN THE PROXIMAL PART OF THE SVG, AND AN ADDITIONAL 4.0X48 MM NON-MEDTRONIC STENT POST-DILATED WITH A 4.0-MM NC BALLOON AT 14 ATM WAS PLACED AT THE MID-DISTAL SEGMENT OF THE SVG. FOUR MONTHS LATER, THE PATIENT WAS HOSPITALIZED WITH A NON¿ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, AND THE LEFT VENTRICULAR EJECTION FRACTION HAD DECLINED TO 30%. CORONARY ANGIOGRAPHY SHOWED A 2-LAYERED STENT FRACTURE OF THE PROXIMAL PART OF THE SAPHENOUS VEIN GRAFT AND IN-STENT RESTENOSIS OF THE PROXIMAL STENT FRACTURE CAUSED BY RECURRENT SF. THE SVG WAS MANAGED USING A 7F CORONARY GUIDING CATHETER, WITH IMPLANTATION OF A 5.0 × 40.0 MM NON-MEDTRONIC PERIPHERAL SELF-EXPANDING, FOLLOWED BY POST-DILATATION WITH A 5.0-MM NC BALLOON AT 16 ATM. THE PROCEDURE WAS COMPLETED WITH INFLATION OF A 4.0 × 40.0 MM NON-MEDTRONIC SIROLIMUS-ELUTING BALLOON. SIXTEEN MONTHS LATER, THE PATIENT PRESENTED AGAIN WITH NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. LEFT VENTRICULAR EJECTION FRACTION WAS STABLE AT 30%. ANGIOGRAPHY SHOWEDA SIGNIFICANT STENOSIS OF THE SVG AT THE SITE OF THE AORTIC ANASTOMOSIS, PROXIMALLY TO THE IMPLANTED NITINOL STENT, WHILE THE NITINOL STENT WAS FREE OF RESTENOSIS AND SHOWED NO SIGN OF FRACTURE. IN ADDITION, AN INTERMEDIATE IN-STENT RESTENOSIS WAS OBSERVED IN THE MID AND DISTAL PORTIONS OF THE SVG. THE OSTIUM OF THE SVG WAS TREATED WITH A 4.0X12.0MM NON-MEDTRONIC SIROLIMUS-ELUTING STENT, POST-DILATED WITH A 4.0-MM NC BALLOON AT 20 ATM AND THE INTERMEDIATE STENOSIS WAS TREATED WITH THE SAME 4.0-MM NC BALLOON. IT WAS REPORTED THAT THE PATIENT¿S HOSPITAL COURSE WAS COMPLICATED 2 DAYS LATER BY A PULSELESS WIDE-COMPLEX TACHYCARDIA (300/MIN), SUGGESTIVE OF AN ATRIAL FLUTTER WITH 1:1 CONDUCTION AND PREEXISTING COMPLETE RIGHT BUNDLE BRANCH BLOCK DOCUMENTED ON A RHYTHM STRIP LASTING 2 MINUTES AND FOLLOWED BY SPONTANEOUS CARDIOVERSION. IN THE POST-ARRHYTHMIA ELECTROCARDIOGRAM, NO SIGNS OF ACUTE ISCHEMIA WERE IDENTIFIED. SUBSEQUENTLY, THE PATIENT EXPERIENCED HEART FAILURE, STROKE, AND DEATH. THE TROPONIN LEVELS ROSE TO 3,720 NG/L, AND THE CREATINE KINASE PLATEAUED AT 480 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697320 RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC IRELAND RONYX40038X

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention| D