BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFERA

    MDR report key: 22485569 · Received July 11, 2025

    Report

    Report Number
    3012520654-2025-00093
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    July 2, 2025
    Report Date
    July 11, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    QZI
    PMA / PMN Number
    P240013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/59 YEARS OLD. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: SAFETY AND EFFICACY OF A LATTICE-TIP CATHETER FOR VENTRICULAR ARRHYTHMIA 1 ABLATION: 2 THE AFFERA VENTRICULAR ARRHYTHMIA ABLATION (AVAAR) REGISTRY. EP EUROPACE ¿ EHJ ARRHYTHMIAS AND ELECTROPHYSIOLOGY; 2025; EUAF139 DOI.ORG/10.1093/EUROPACE/EUAF13 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

    LITERATURE WAS REVIEWED REGARDING THIS STUDY AIMED TO ASSESS FEASIBILITY, SAFETY PROFILE AS WELL AS PATIENT OUTCOMES AFTER VENTRICULAR ARRHYTHMIA (VA) ABLATION WITH A LATTICE-TIP CATHETER IN A MULTICENTER EUROPEAN REGISTRY. THE AUTHORS DESCRIBED FOUR PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE MULTI-ORGAN FAILURE (2), SEPSIS(2) AND VT STORM (1). ONE PATIENT DIED IN INTENSIVE CARE UNIT (I CU). THERE WERE PATIENTS WHO EXPERIENCED INTRAOPERATIVE COMPLICATIONS WHICH INCLUDED TWO MAJOR BLEEDING (ONE REQUIRING BLOOD TRANSFUSION AND ONE REQUIRING ADDITIONAL VASCULAR SURGERY), ONE TAMPONADE DUE TO EPICARDIAL ACCESS WITH CORONARY LACERATION AND MYOCARDIAL INFARCTION, ONE CARDIOGENIC SHOCK (REQUIRED CARDIOPULMONARY RESUSCITATION (CPR) AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THIS PATIENT EVENTUALLY RECOVERED AND WAS DISCHARGED.), TWO THROMBO-EMBOLIC EVENTS - STROKE (FULL NEUROLOGIC RECOVERY), ONE VENTRICULAR FIBRILLATION (VF), ATRIAL FIBRILLATION (AF) WAS INDUCED, THREE FEMORAL ACCESS ISSUES, ONE ATELECTASIA, ONE PERICARDITIS, EIGHT TRANSIENT ST ELEVATION/DEPRESSION POST APPLICATION, CORONARY SPASMS, THREE BIOLOGICAL HEMOLYSIS, ONE MECHANICAL LEFT BUNDLE BRANCH BLOCK (LBBB) AND ONE LV CHORDAE RUPTURE BY CATHETER MANIPULATION BUT WITHOUT CONSEQUENCE -ENTRAPMENT (NO CHANGE IN MITRAL VALVE INSUFFICIENCY WAS NOTED.). TREATMENTS INCLUDED MEDICATIONS FOR THE ST ELEVATIONS/SPASMS AND PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE MYOCARDIAL INFARCTION. POSTOPERATIVE COMPLICATIONS INCLUDED TWO HEART FAILURES AFTER DAY 1, ONE MYOCARDIAL INFARCTION, ONE SEPSIS AND ONE MAJOR GASTRO-INTESTINAL BLEED. RECURRENCE OF VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) WERE NOTED. THE CATHETER EXHIBITED INFERENCE AND A RUPTURED SHAFT. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895667 AFFERA PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI MEDTRONIC, INC. AFR-00001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Life Threatening| R AFR-00001 CATHETER