BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILIS¿ INTRODUCER, UNKNOWN

    MDR report key: 9879250 · Received March 25, 2020

    Report

    Report Number
    3008452825-2020-00166
    Event Type
    Death
    Date Received
    March 25, 2020
    Report Date
    April 6, 2020
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CEREBRAL VASCULAR ACCIDENT REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REF: 3005334138-2020-00127, 3005334138-2020-00128, 3008452825-2020-00167. THE FOLLOWING WAS PUBLISHED IN THE IJC HEART & VASCULATURE 26 (2020) 100459 IN AN ARTICLE TITLED ¿EUROPEAN MULTICENTRE EXPERIENCE OF STAGED HYBRID ATRIAL FIBRILLATION ABLATION FOR THE TREATMENT OF PERSISTENT AND LONGSTANDING PERSISTENT ATRIAL FIBRILLATION¿ BY G.A. HAYWOOD, RECEIVED 31 AUGUST 2019. THE MANAGEMENT OF NON-PAROXYSMAL ATRIAL FIBRILLATION (AF) REMAINS CONTROVERSIAL. WE EXAMINED THE EFFICACY AND SAFETY OF THE 2 STAGE HYBRID AF ABLATION APPROACH BY ANALYSING THE LARGEST SERIES OF THIS TECHNIQUE REPORTED SO FAR. METHODS: THE APPROACH AIMS TO ELECTRICALLY ISOLATE THE LEFT ATRIAL POSTERIOR WALL INCORPORATING THE PULMONARY VEINS (¿BOX-SET¿PATTERN). AN INITIAL VIDEO-ASSISTED THORACOSCOPIC (VATS) EPICARDIAL ABLATION IS FOLLOWED AFTER A MINIMUM OF 8 WEEKS BY ENDOCARDIAL RADIOFREQUENCY CATHETER ABLATION. RESULTS: OF 175 PATIENTS FROM 4 EUROPEAN CARDIOTHORACIC CENTERS, WHO UNDERWENT THE SURGICAL (COBRA FUSION, ATRICURE INC) 1ST STAGE ABLATION, 166 WENT ON TO COMPLETE 2ND STAGE CATHETER ABLATION. AT MEDIAN FOLLOW UP OF 18 MONTHS POST 2ND STAGE PROCEDURE 93/166 (56%) HAD REMAINED FREE OF AF OR ATRIAL TACHYCARDIA (AT) RECURRENCE OFF ANTIARRHYTHMIC DRUGS. 110/175 62.9% WERE IN SINUS RHYTHM OFF ALL ANTIARRHYTHMIC DRUGS AT LAST CLINIC FOLLOW-UP (132/175 75.4% INCLUDING THOSE ON ANTIARRHYTHMIC DRUGS). 18 PATIENTS (10.8%) UNDERWENT A FURTHER RE-DO ABLATION (MEAN OF 1.1 ABLATIONS PER PATIENT) 105/166 (63%) REMAINED FREE OF AF/AT RECURRENCE OFF ANTIARRHYTHMIC DRUGS FOLLOWING LAST ABLATION PROCEDURE. LATTERLY, ILRS HAVE BEEN IMPLANTED IN PATIENTS (N = 56); 60% HAVE REMAINED FULLY ARRHYTHMIA FREE AND 80% HAVE SHOWN AF BURDEN < 5% AT A MEDIAN 14 MONTHS FOLLOW-UP [IQR: 13.5 (8¿21.5)]. ONLY 10.9% HAVE REVERTED TO PERSISTENT AF. 5 PATIENTS (2.9%) HAD A PERIOPERATIVE STROKE AND 4 PATIENTS (2.3%) EXHIBITED PERSISTENT WEAKNESS OF THE RIGHT HEMIDIAPHRAGM FOLLOWING STAGE 1 VATS EPICARDIAL ABLATION. ONE PATIENT DIED FOLLOWING STROKE (OVERALL MORTALITY 0.6%). CONCLUSIONS: IN PATIENTS WITH NON-PAROXYSMAL AF WITH UNFAVOURABLE CHARACTERISTICS FOR CATHETER ABLATION, THE STAGED HYBRID APPROACH RESULTS IN ACCEPTABLE LEVELS OF FREEDOM FROM RECURRENT ATRIAL ARRHYTHMIA, HOWEVER, COMPLICATION RATES ARE HIGHER THAN WITH CATHETER ABLATION ALONE. THE PATIENT EXPERIENCED A STROKE WHICH RESULTED IN DEATH. CONCOMITANT DEVICES: SWARTZ INTRODUCER X 2, AGILIS INTRODUCER X 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340940 AGILIS¿ INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death