PENDITURE LAA EXCLUSION 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.

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A PENDITURE DEVICE, IT WAS REPORTED THAT THE CLIP ALLEGEDLY MIGRATED APPROXIMATELY 1CM AFTER THE INITIAL PLACEMENT. THEY MEASURED A 40MM CLIP AND PLACED IT. THE CLIP WAS CAPTURED AND REPOSITIONED BUT IT SLID AGAIN AFTER REPOSITIONING. THE DECISION WAS MADE TO LEAVE THE CLIP IN PLACE TO AVOID POTENTIAL BLEEDING AND A LONGER PUMP RUN. THE PATIENT WAS CLOSED UP AND LEFT WITH A RECESS DUE TO THE CLIP MIGRATING TWICE. THE TISSUE WAS NOTED TO BE THICKER THAN NORMAL WHICH MAY HAVE CONTRIBUTED TO THE MIGRATION BUT OTHERWISE EVERYTHING WAS NORMAL. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION B5. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER ALWAYS USES THE SIZER TO CONFIRM THE CLIP SIZE. 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.