BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAILBLAZER SUPPORT CATHETER

    MDR report key: 10453234 · Received August 26, 2020

    Report

    Report Number
    2183870-2020-00268
    Event Type
    Injury
    Date Received
    August 26, 2020
    Date of Event
    July 2, 2020
    Report Date
    December 11, 2020
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K092299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: MANAGEMENT OF COMPLICATIONS DURING BELOW-THE-KNEE ENDOVASCULAR TREATMENT: A TECHNICAL NOTE JOURNAL: KOREAN JOURNAL OF RADIOLOGY YEAR: 2020 REF: DOI: 10.3348/KJR.2019.0743. DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS LITERATURE ARTICLE REPORTS IS A RETROSPECTIVE STUDY WHICH REVIEWED THE CASES IN WHICH COMPLICATIONS OCCURRED DURING BELOW-THE-KNEE (BTK) ENDOVASCULAR TREATMENTS THAT WERE PERFORMED AT OUR HOSPITAL FROM 2005 TO 2014. TEN CASES HAVE BEEN DESCRIBED HEREIN. ALL THE PATIENTS HAD DIABETES AND NON-HEALING WOUNDS ON THEIR FEET AND/OR REST PAIN IN THEIR FOOT OR LEG, AND THEREFORE, ENDOVASCULAR TREATMENT WAS PERFORMED FOR THE BTK ARTERIES OF THE AFFECTED LOWER EXTREMITY. THE COMPLICATIONS THAT OCCURRED DURING THE PROCEDURE WERE CLASSIFIED INTO SIX CATEGORIES¿VASCULAR SPASM, FLOW LIMITING DISSECTION, PERFORATION, BROKEN GUIDEWIRE, DISTAL THROMBOEMBOLISM, AND UNUSUAL PUNCTURE SITE BLEEDING. EACH COMPLICATION HAS ITS OWN SOLUTIONS AND MANAGEMENT. ENDOVASCULAR PROCEDURES WERE PERFORMED UNDER LOCAL ANESTHESIA BY INTERVENTIONAL RADIOLOGISTS IN AN INTERVENTIONAL RADIOLOGY SUITE. THE COMMON FEMORAL ARTERY (CFA) WAS PUNCTURED USING A NON-MEDTRONIC MICROPUNCTURE SET UNDER ULTRASOUND GUIDANCE AND SHEATH INSERTION WAS PERFORMED. ANGIOGRAPHY USING NON-IONIC CONTRAST MEDIUM OR CARBON DIOXIDE (FOR PATIENTS WITH POOR RENAL FUNCTION) AND DIGITAL SUBTRACTION ANGIOGRAPHY WERE PERFORMED THROUGH THE SHEATH TO EVALUATE ENTIRE LOWER EXTREMITY ARTERIES. IN ADDITION TO THOSE WITH ONLY BTK ARTERY LESIONS, SOME PATIENTS HAD LESIONS IN THE ILIO-FEMOROPOPLITEAL ARTERIES. ALTHOUGH ALL AFFECTED ARTERIES WERE TREATED IN THESE PATIENTS, THIS REPORT ONLY INVESTIGATED THE TREATMENT OF BTK ARTERIES. THE STENO-OCCLUSIVE LESIONS OF THE BTK ARTERIES WERE CROSSED USING DEDICATED 0.018 OR 0.014 INCH NON-MEDTRONIC GUIDEWIRES. A TRAILBLAZER SUPPORT CATHETER AND A NON-MEDTRONIC GUIDING SHEATH WERE USED TO PROVIDE BETTER SUPPORT. AN ANTEGRADE APPROACH WAS INITIALLY ATTEMPTED BY PUNCTURING THE CFA. IN CASES WITH RESTRICTED OR NO ACCESS THROUGH THE CFA, WE ATTEMPTED RETROGRADE ACCESS VIA THE DISTAL BTK VESSELS. IN SOME CASES, A PEDAL OR PLANTAR ARTERY APPROACH WAS ALSO ATTEMPTED. THE BTK LESION WAS PASSED USING THESE APPROACHES AND BALLOON ANGIOPLASTY WAS THEN PERFORMED. DURING THE PROCEDURE, COMPLICATIONS WERE DETECTED WITH A FOLLOW-UP ANGIOGRAM AND APPROPRIATELY MANAGED. AT THE END OF THE PROCEDURE, WE CONFIRMED THE ESTABLISHMENT OF BLOODFLOW IN AT LEAST ONE BTK ARTERY TO ENSURE PERFUSION TO THE PATIENT¿S FOOT. CASE 3: THE PATIENT WAS ADMITTED WITH THE PRIMARY SYMPTOMS OF REST PAIN AND COLDNESS IN HIS LEFT FOOT. ANGIOPLASTY WAS PERFORMED FOR A LONG-SEGMENT OCCLUSION OF THE POSTERIOR TIBIAL ARTERY (PTA) WITH A 2.5 MM X 12 CM BALLOON (AMPHIPRION DEEP). AFTER 15 MINUTES OF INFLATION, A FOLLOW-UP ANGIOGRAPHY SHOWED NO FLOW BELOW THE PROXIMAL PTA AND DISSECTION IN THE PROXIMAL PTA . A 3 MM X 18 MM NON-MEDTRONIC DRUG-ELUTING CORONARY STENT WAS DEPLOYED ON THE LESION AND THE FLOW WAS RESTORED. DOPPLER ULTRASONOGRAPHY SCAN AT 14-MONTH FOLLOW-UP REVEALED THAT THE STENT PATENCY WAS WELL MAINTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921428 TRAILBLAZER SUPPORT CATHETER CATHETER, PERCUTANEOUS DQY COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention