ENDO CLIP II

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

IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY USING A CLIP APPLIER, THE CYSTIC DUCT WAS CLIPPED AND THEN PARTIALLY TRANSECTED TO PERFORM AN INTRAOPERATIVE CHOLANGIOGRAM WHEN INTRAOPERATIVE BLEEDING BEGAN FROM AN UNIDENTIFIED SOURCE. THE CLIP APPLIER WAS APPLIED AT THE CYSTIC DUCT AND, WHILE THE HANDLE COULD BE SQUEEZED, THE DEVICE JAWS WERE REPORTEDLY NOT ABLE TO CLOSE, WITH SUSPECTED INCOMPLETE CLIP CLOSURE AND CONTINUED BLEEDING. BLOOD LOSS OF 500 CC OR MORE WAS REPORTED, AND THE TISSUE DAMAGE WAS PERMANENT. A SECOND CLIP APPLIER WAS OPENED AND FIRED ON SUSPECTED BLEEDING TISSUE, AND THE CLIPS REPORTEDLY HELD, BUT THE BLEEDING SOURCE COULD NOT BE IDENTIFIED. THE PATIENT CODED AND WAS RESUSCITATED, THEN THE PROCEDURE WAS CONVERTED TO OPEN SURGERY TO ATTEMPT TO FIND THE BLEEDING VESSEL, AND THE INCISION WAS EXTENDED MORE THAN 1 INCH (2.54 CM). THE PATIENT CODED A SECOND TIME AND DIED DURING THE PROCEDURE.