BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOCOLATE

    MDR report key: 16184458 · Received January 17, 2023

    Report

    Report Number
    2183870-2023-00017
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    October 27, 2022
    Report Date
    January 17, 2023
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    PMA / PMN Number
    K130414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL TITLE VESSEL PREPARATION WITH CHOCOLATE PTA BALLOON CATHETER IN FEMOROPOPLITEAL LESIONS EUROPEAN JOURNAL OF VASCULAR MEDICINE UNION OF VASCULAR SOCIETIES OF SWITZERLAND VOLUME 51 / SUPPLEMENT 108 / 2022 HTTPS://ECONTENT.HOGREFE.COM/DOI/PDF/10.1024/0301-1526/A001036 B3 DATE OF PUBLICATION 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A LITERATURE ARTICLE ABSTRACT TITLED 'VESSEL PREPARATION WITH CHOCOLATE PTA BALLOON CATHETER IN FEMOROPOPLITEAL L ESIONS'. OBJECTIVE: VESSEL PREPARATION BEFORE ANGIOPLASTY WITH A DRUG-COATED BALLOON (DCB) IN FEMOROPOPLITEAL LESIONS IS CRUCIAL TO IMPROVING DRUG DELIVERY EFFICACY TO THE ARTERIAL WALL. PLAIN OLD BALLOON ANGIOPLASTY IS STILL USED TO PREPARE THE VESSEL, BUT LIMITATIONS SUCH AS DISSECTION AND RESIDUAL STENOSIS ARE FREQUENTLY OBSERVED. THE STUDY AIMS TO EVALUATE THE EFFICACY AND SAFETY OF A NITINOL-CAGED BALLOON (CHOCOLATE PTA BALLOON CATHETER) ASSOCIATED WITH DCB IN FEMOROPOPLITEAL LESIONS. METHODS: THIS OBSERVATIONAL RETROSPECTIVE STUDY WAS CONDUCTED ON ALL CONSECUTIVE PATIENTS RECEIVING NITINOL CAGED BALLOON ANGIOPLASTY FOR FEMOROPOPLITEAL LESIONS FROM 2020 TO 2021. VESSEL PREPARATION WAS PERFORMED USING THE CHOCOLATE PTA BALLOON, FOLLOWED BY SYSTEMATIC DRUG-ELUTING BALLOON INFLATION. THE DUPLEX SCAN AND CLINICAL VISIT GUARANTEED THE FOLLOW-UP. THE PATENCY RATE AND CLINICAL-DRIVEN TARGET REVASCULARISATION (CDTLR) WERE ANALYSED USING KAPLAN MEIER. STANDARD STATISTICAL ANALYSIS WAS USED TO EVALUATE THE SAFETY AND EFFICACY OF THE TREATMENT. RESULTS: 35 PATIENTS (18 MALES; THE MEDIAN AGE OF 77 YEARS) WERE INCLUDED SUFFERING FROM INTERMITTENT CLAUDICATION (58.3 %) OR CHRONIC LIMB-THREATENING ISCHEMIA (38.9 %). THE GLOBAL LIMB ANATOMIC STAGING SYSTEM (GLASS) FOR THE 35 LIMBS ANALYSED INCLUDED 2(5.7 %) STAGE1, 18 (51.4 %) STAGE 2 AND 15 (42.9 %) STAGE 3. THE MEDIAN LENGTH OF THE LESIONS WAS 67 48.1 MM. OCCLUSION OF THE SUPERFI CIAL FEMORAL ARTERY WAS PRESENT IN 12.5 %. ALL PATIENTS WERE TREATED WITH A NITINOL-CAGED BALLOON FOLLOWED BY DCB (93.8 %), AND THE BAILOUT STENTING RATE WAS 28.6 % (10/35), MAINLY RELATED TO TYPE C DISSECTION. MAJOR ADVERSE EVENTS AND UNPLANNED MAJOR AMPUTATION OCCURRED IN 2.9 % OF THE CASES. THE MEAN FOLLOW-UP WAS 8.6 AT 4.7 MONTHS; THE PRIMARY PATENCY WAS 96.8 % AT SIX MONTHS. FREEDOM FROM CDTLR WAS 96.8 % AT SIX MONTHS. ABI AT SIX MONTHS WAS SIGNIFICANTLY HIGHER CONCERNING PREOPERATIVE VALUES (P=0.035). CONCLUSION: THESE EARLY RESULTS DEMONSTRATED THAT COMBINING A CHOCOLATE PTA BALLOON CATHETER AND A DRUG-ELUTING BALLOON IS SAFE AND EFFICIENT EVEN IF THE BAILOUT STENTING RATE IS STILL TOO HIGH, WHICH IS ALSO RELATED TO THE EARLY EXPERIENCE WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134817 CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown