BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE ONYX RX

    MDR report key: 21430385 · Received February 21, 2025

    Report

    Report Number
    9612164-2025-00943
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    November 11, 2024
    Report Date
    March 19, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    K. GENDERA, P. BAMBUL HECK, A. EICKEN, D. TANASE, P. EWERT, M. VON STUMM, S. GEORGIEV. "SERIAL DILATION AND INTENTIONAL FRACTURING OF STENTS IN CONGENITAL HEART DISEASE - BENCHSIDE TESTS AND INITIAL CLINICAL RESULTS". CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, NO. 105, 2024, DOI.ORG/10.1002/CCD.31309. PMID: 39623598. PAGES: 150-157. 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 CODES. 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 "SERIAL DILATION AND INTENTIONAL FRACTURING OF STENTS IN CONGENITAL HEART DISEASE - BENCHSIDE TESTS AND INITIAL CLINICAL RESULTS". THIS RETROSPECTIVE STUDY PRESENTS THE RESULTS OF BENCH SIDE TESTS OF INTENTIONAL STENT FRACTURING, AND THE INITIAL CLINICAL EXPERIENCE IN SMALL PATIENTS WITH CONGENITAL HEART DISEASES. TO PROVE THE EFFICIENCY OF THE STRATEGY FOR TREATING SMALL CHILDREN WITH STENT IMPLANTATION, A SERIES OF BENCH SIDE TESTS FOR DIFFERENT BRAND STENTS, INCLUDING THE MEDTRONIC RESOLUTE ONYX STENT, WERE PERFORMED AS A FIRST STEP. STENTS WERE SERIAL DILATATED WITH HIGH PRESSURE BALLOONS WITH INCREASING SIZES (NO MORE THAN 2MM DIFFERENCE IN DIAMETER OF THE FOLLOWING BALLOONS). THE STRATEGY OF SECOND-STENT IMPLANTATION PRECEDING THE FRACTURING PROCEDURE WAS ALSO TESTED ON THE BENCH SIDE. TESTS WERE CARRIED OUT UNTIL THE STENT WAS FRACTURED AND THE MAXIMAL DIAMETER OF THE STENT BEFORE CRACKING WAS REPORTED AND NAMED ¿FRACTURING SIZE.¿ SEVENTEEN PATIENTS WERE TREATED WITH STENTS THAT WERE SUBSEQUENTLY INTENTIONALLY FRACTURED. IN THE PATIENT TESTS, A STENT WAS CONSIDERED TO BE FRACTURED IF IT WAS EXPANDED ABOVE ITS FRACTURING SIZE, AND IF NO RESIDUAL WAIST ON THE BALLOON WAS SEEN IN THE FINAL FLUOROSCOPY. FOLLOWED BY ONE PEDIATRIC PATIENT WITH SUPRA PULMONARY STENOSIS (PS), SUPRA AORTIC STENOSIS (AS) AND ELASTINE DEFECT, WAS TREATED WITH A 5MM RESOLUTE ONYX STENT OVER TO THE PROXIMAL RIGHT PULMONARY ARTERY (RPA), DURING THE INITIAL IMPLANTATION PROCEDURE. AFTER STENT IMPLANTATION, SERIAL DILATATIONS TO ADAPT THE DIAMETER OF THE STENT TO VESSEL GROWTH WAS PERFORMED. APPROXIMATELY 27 MONTHS POST INITIAL STENT IMPLANTATION, IMPLANTATION OF A NON-MEDTRONIC LARGER STENT AND SUBSEQUENT INTENTIONAL FRACTURING OF THE INITIAL RESOLUTE ONYX STENT WAS PERFORMED WITH AM 8MM ULTRA-HIGH-PRESSURE NON-MEDTRONIC BALLOON TO 32 ATM. STENT FRACTURING WAS SUCCESSFUL, AND NO BALLOON RUPTURE WAS OBSERVED. NO BLEEDING OR OTHER SERIOUS COMPLICATIONS RELATED TO THE FRACTURING WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621295 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO Unknown