BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER OTW

    MDR report key: 17676036 · Received September 4, 2023

    Report

    Report Number
    9612164-2023-03994
    Event Type
    Injury
    Date Received
    September 4, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 18, 2023
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ANNEX D CODE. 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.

    Additional Manufacturer Narrative · 0

    VASILEIOS SOUSONIS, STÉPHANE COMBES, PAULINE PINON, NICOLAS COMBES, CHRISTELLE CARDIN, SARAH ZERIOUH, ROBERTO MENÈ, SOPHIE JACOB, SERGE BOVEDA AND JEAN PAUL ALBENQUE, "A NOVEL STEPWISE APPROACH INCORPORATING ETHANOL INFUSION IN THE VEIN OF MARSHALL FOR THE ABLATION OF PERSISTENT ATRIAL FIBRILLATION." FRONTIERS IN CARDIOVASCULAR MEDICINE, 2023, DOI: 10.3389/FCVM.2023.1194687. PMID: 37304968. A2: AVERAGE AGE A3: MAJORITY GENDER 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

    A JOURNAL ARTICLE WAS SUBMITTED FOR REVIEW TITLED "A NOVEL STEPWISE APPROACH INCORPORATING ETHANOL INFUSION IN THE VEIN OF MARSHALL FOR THE ABLATION OF PERSISTENT ATRIAL FIBRILLATION". THIS WAS A PROSPECTIVE STUDY WHICH INVESTIGATED THE FEASIBILITY AND LONG-TERM OUTCOMES OF A NOVEL STEPWISE ABLATION PROCEDURE INCORPORATING A STEP OF ETHANOL INFUSION IN THE VEIN OF MARSHALL (VOM) FOR PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION (AF). FROM NOVEMBER 2019 TO JUNE 2020, 66 PATIENTS WITH SYMPTOMATIC PERSISTENT AF AND FAILURE OF AT LEAST ONE ANTIARRHYTHMIC DRUG (AAD) WERE PROSPECTIVELY ENROLLED IN THE STUDY. THE SEQUENTIAL STEPWISE ABLATION WITH THE FOLLOWING PROGRESSIVE STEPS WAS PERFORMED IN ALL PATIENTS: (I) RADIOFREQUENCY (RF) WIDE ANTRAL PULMONARY VEIN ISOLATION (PVI), (II) VOM ETHANOL INFUSION AND ATRIAL SEGMENTATION WITH THE DEPLOYMENT OF LINEAR RF LESIONS AT THE MITRAL ISTHMUS AND THE ROOF OF THE LEFT ATRIUM (ADDITIONAL EPICARDIAL ABLATION THROUGH THE CORONARY SINUS [CS] WAS PERFORMED TO ACHIEVE MITRAL ISTHMUS BLOCK, IF NEEDED) AND (III) FOCAL RF ABLATION TARGETING AREAS OF ELECTROGRAM DISPERSION IN THE LEFT ATRIUM IN SPATIOTEMPORAL DISPERSION ZONES. REGARDLESS OF AF TERMINATION, THE PROCEDURE WAS CARRIED ON UNTIL THE END OF THE SECOND STEP IN ALL PATIENTS, TO ENSURE COMPLETE ATRIAL SEGMENTATION. IF AF PERSISTED AT THE END OF THE SECOND STEP, ELECTROGRAM-BASED ABLATION OF DISPERSION ZONES WAS PERFORMED WITH THE ENDPOINT OF SINUS RHYTHM RESTORATION. IF AF PERSISTED AT THE END OF THE THIRD STEP, ELECTRICAL CARDIOVERSION WAS PERFORMED TO RESTORE SINUS RHYTHM. IN CASE AF EVOLVED INTO AN ATRIAL TACHYCARDIA (AT) DURING ANY OF THE ABOVE STEPS, CONVENTIONAL AT MAPPING AND ABLATION WAS PERFORMED. AT THE END OF THE PROCEDURE, RF ABLATION OF THE CAVO-TRICUSPID ISTHMUS WAS CARRIED OUT IN ALL PATIENTS, IF NOT PREVIOUSLY PERFORMED AS PART OF THE ABLATION OF AN INTERMEDIATE AT. AFTER RESTORATION OF SINUS RHYTHM, ENTRY AND EXIT BLOCK WAS ASSESSED AT THE PULMONARY VEINS (PV) ANTRA AND BIDIRECTIONAL BLOCK AT EVERY ABLATION LINE. IN CASE OF INCOMPLETE LESIONS, ADDITIONAL RF APPLICATIONS WERE ADMINISTERED. RF ABLATIONS WERE PERFORMED WITH A NON-MEDTRONIC (MDT) ABLATION CATHETER. FOR THE ETHANOL INFUSION IN THE VOM, THE CS WAS CANNULATED WITH A NON-MDT FIXED CURVE OR A DEFLECTABLE SHEATH. A LEFT INTERNAL MAMMARY ARTERY GUIDE CATHETER WAS THEN USED FOR ANGIOGRAPHIC CONTRAST INJECTION AND LOCALIZATION OF THE OSTIUM OF THE VOM, WHICH WAS THEN SUB-SELECTIVELY CANNULATED. A NON-MDT ANGIOPLASTY GUIDEWIRE WAS ADVANCED INTO THE VOM AND A PRE-LOADED OVER-THE-WIRE MEDTRONIC SPRINTER ANGIOPLASTY BALLOON, 1.5 OR 2 MM IN DIAMETER WAS THEN ADVANCED INTO THE PROXIMAL VOM AND INFLATED. VOM ANATOMY AND OCCLUSION WERE CONFIRMED BY A VENOGRAM. AFTERWARDS, 5 TO 6 ML OF ETHANOL (100%) WERE INJECTED SLOWLY THROUGH THE CENTRAL BALLOON LUMEN AND THE BALLOON WAS DEFLATED. AADS WERE CONTINUED FOR 30 TO 90 DAYS AFTER THE ABLATION PROCEDURE. ALL PATIENTS WERE FOLLOWED-UP WITH CLINICAL VISITS AND 48-HOUR HOLTER MONITORING AT 3, 6, AND 12 MONTHS. THE PRIMARY ENDPOINT WAS FREEDOM FROM ANY ASYMPTOMATIC OR SYMPTOMATIC ATRIAL TACHYARRHYTHMIA LASTING MORE THAN 30 SECONDS, AFTER A SINGLE PROCEDURE AND AN INITIAL 3-MONTH BLANKING PERIOD. REPEATED ABLATION WAS OFFERED TO PATIENTS WITH ARRHYTHMIA RECURRENCES. DURING THE PROCEDURE, AF TERMINATED DIRECTLY TO SINUS RHYTHM IN 22 PATIENTS, AND WAS CONVERTED TO AN INTERMEDIATE AT IN 16 PATIENTS. TWENTY-EIGHT PATIENTS REQUIRED ELECTRICAL CARDIOVERSION AT THE END OF THE PROCEDURE TO RESTORE SINUS RHYTHM. PVI WAS ACHIEVED IN ALL PATIENTS, AND AF TERMINATED TO SINUS RHYTHM SOLELY BY PVI IN 5 PATIENTS. THIRTEEN PATIENTS DID NOT HAVE DISPERSION-TARGETED ABLATION SINCE SINUS RHYTHM HAD ALREADY BEEN RESTORED PRIOR TO THIS FINAL STEP. BIDIRECTIONAL BLOCK AT THE MITRAL ISTHMUS WAS ACHIEVED IN 56 PATIENTS, AT THE LA ROOF IN 59 PATIENTS, AND AT THE CAVO-TRICUSPID ISTHMUS IN 63 PATIENTS. ONE PATIENT DEVELOPED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. ANOTHER PATIENT EXPERIENCED A GROIN HEMATOMA, WHICH WAS MANAGED CONSERVATIVELY. AFTER A SINGLE PROCEDURE, 54 PATIENTS REMAINED FREE FROM AF OR AT RECURRENCES AT 12 MONTHS. FIVE PATIENTS HAD RECURRENT PERSISTENT AF, WHILE 7 PATIENTS PRESENTED WITH A MACRO RE-ENTRANT AT (5 PATIENTS WITH A PERI-MITRAL AND 2 PATIENTS WITH A ROOF-DEPENDENT LA FLUTTER). AT THE END OF THE FOLLOW-UP PERIOD, 43 PATIENTS NO LONGER REQUIRED AN AAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412534 SPRINTER OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, LOX MEDTRONIC MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention