ENDO CLIP

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

ACCORDING TO THE REPORTER, DURING CLIPPING OF THE CYSTIC ARTERY, THE HANDLE OF THE CLIP APPLIER WAS NOT SQUEEZED, AND THE INITIAL FIRING FAILED TO DEPLOY A CLIP. UPON REPEAT ACTIVATION, THE FIRING MECHANISM ADVANCED WITHOUT DEPLOYING A CLIP, RESULTING IN TRANSECTION OF THE CYSTIC ARTERY AND SIGNIFICANT BLEEDING. ATTEMPTS TO FIRE THE CLIP APPLIER OUTSIDE THE PATIENT ALSO FAILED TO DEPLOY ANY CLIPS. THE MALFUNCTION CAUSED SIGNIFICANT BLOOD LOSS AND MASSIVE HEMORRHAGE, PROMPTED A CODE PROTOCOL, AND RESULTED IN THE PATIENT BEING ADMITTED TO THE ICU. IT WAS CONFIRMED THAT THE PATIENT IS DOING WELL WITH NO FURTHER COMPLICATIONS IN HOSPITAL AND HAS BEEN DISCHARGED HOME.