PENDITURE LAA EXCLUSION SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ELECTROPHYSIOLOGIST WAS CONSULTED. THE END DATE OF THE HOSPITALIZATION WAS (B)(6) 2024. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERING/RESOLVING. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ADVERSE EVENT WAS DEEMED BY THE SITE AS NOT RELATED TO THE PENDITURE CLIP DEVICE AND THE PENDITURE DELIVERY SYSTEM. THE OUTCOME OF THE ADVERSE EVENT WAS RECOVERED/RESOLVED WITH SEQUELAE. CORRECTION B5: THE PATIENT HAD AN ELECTROCARDIOGRAM ON (B)(6) 2024. THE ELECTROCARDIOGRAM SHOWED ATRIAL FIBRILLATION WITH ABERRANT VENTRICULAR BEATS. IT WAS STATED THAT THIS WAS CLINICALLY SIGNIFICANT. A BLOOD TEST WAS CARIED OUT ON (B)(6) 2024, AND THE RESULT ARE STAT ELECTROLYTES SENT. IT WAS STATED THAT THE RESULTS WERE NOT CLINICALLY SIGNIFICANT. THE OUTCOME OF THE ADVERSE EVENT IS UNKNOWN, AND THE PATIENT HAS BEEN HOSPITALIZED SINCE (B)(6) 2024. 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

MEDTRONIC RECEIVED INFORMATION THROUGH THE CLIP-IT CLINICAL POST-MARKET STUDY, THAT FOLLOWING A PROCEDURE INVOLVING USE OF THE PENDITURE CLIP ON (B)(6) 2024, THE CUSTOMER REPORTED THE PATIENT HAD ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE WITH INTERMITTENT SUPRAVENTRICULAR TACHYCARDIA ON (B)(6) 2024, AND WAS SUCCESSFULLY TREATED FIRSTLY WITH ANTICOGUALNTS (START DATE-UNKNOWN -2021, END DATE- (B)(6) 2024), ASPIRIN (START DATE-(B)(6) 2024, END DATE- ONGOING) , ANTICOAGULANT (START DATE-(B)(6) 2024, END DATE- ONGOING), CLASS III ANTIARRHYTHMICS (START DATE-(B)(6) 2024, END DATE- ONGOING). THE PATIENT HAS HISTORY OF ATRIAL FIBRILLATION, AND IT WORSENED WHILE INPATIENT FOLLOWING PROCEDURE. AMIODARONE IV DRIP STARTED. THE PATIENT HAD A CONCOMITANT SURGICAL PROCEDURE OF ELECTROCARDIOGRAM ON (B)(6) 2024. THIS RESULTED IN ATRIAL FIBRILLATION WITH ABERRANT VENTRICULAR BEATS. THIS WAS CLINICALLY SIGNIFICANT. BLOOD TEST CARIED OUT ON (B)(6) 2024, AND THE RESULT STATES: STAT ELECTROLYTES SENT -CLINICALLY SIGNIFICANT: NO. THE OUTCOME IS UNKNOWN, AND THE PATIENT HAVE BEEN HOSPITALIZED SINCE (B)(6) 2024 THE ADVERSE EVENT WAS DEEMED BY THE SITE AS POSSIBLY RELATED TO THE PENDITURE CLIP DEVICE, BUT NOT RELATED TO THE PENDITURE DELIVERY SYSTEM. THE ADVERSE EVENT WAS DEEMED BY THE SPONSOR AS POSSIBLY RELATED TO THE PENDITURE CLIP DEVICE, BUT NOT RELATED TO THE PENDITURE DELIVERY SYSTEM.

Additional Manufacturer Narrative

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.