PENDITURE LAA EXCLUSION SYSTEM

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) 2025, THE CUSTOMER REPORTED THAT THE PATIENT HAD ATRIAL FIBRILLATION ON (B)(6) 2025, AND IT WAS TREATED WITH CONCOMITANT MEDICATION ADMINISTERED OR ADJUSTED DUE TO THIS ADVERSE EVENT (AE). THE MEDICATION WAS GIVEN INTRAVENOUSLY. THE AE RESULTED IN THE PROLONGATION OF AN EXISTING HOSPITALIZATION FOR THE SUBJECT. K SHOULDERS HAD HELPED AS WELL. THE PATIENT STATED THAT THEY DID NOT FEEL LIKE THEY COULD MOVE AROUND SUFFICIENTLY BUT THEIR ARMS AND LEGS WORKED SUFFICIENTLY. THE PATIENT WENT INTO ATRIAL FIBRILLATION RAPID VENTRICULAR RESPONSE LAST NIGHT WITH THEIR HEART RATE APPROXIMATELY 170 BPM. THEY WERE STARTED ON AMIO PROTOCOL AND DID CONVERT BACK TO NORMAL SINUS RHYTHM (NSR). THEY REMAINED IN NSR WITH THEIR HEART RATE AT APPROXIMATELY 60 BPM. THE OUTCOME OF THE ADVERSE EVENT IS RECOVERING/RESOLVING, AND THE PATIENT HAS BEEN HOSPITALIZED SINCE (B)(6) 2025. THE ADVERSE EVENT WAS DEEMED BY THE INVESTIGATOR AS CASUALLY 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. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SITE UPDATED THE DEVICE RELATIONSHIP TO CLIP AND DELIVERY SYSTEM AS NOT RELATED.

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.