CHOCOLATE

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 A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED USING THE CHOCOLATE 018 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON TO TREAT LOWER EXTREMITY ARTERIOSCLEROSIS OBLITERANS WITH THROMBOSIS INVOLVING A LONG-SEGMENT STENOTIC CALCIFIED PLAQUE LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH 60% STENOSIS, SEVERE CALCIFICATION, AND LITTLE TORTUOSITY. THE BALLOON WAS DILATED SEGMENT BY SEGMENT FROM DISTAL TO PROXIMAL, AND THE FIRST SEGMENT DILATION WAS COMPLETED NORMALLY. AFTER THE SECOND SEGMENT DILATION, RESISTANCE WAS FELT DURING WITHDRAWAL, AND IT WAS OBSERVED THAT THE BALLOON HAD FRACTURED AND DETACHED FROM THE CATHETER/DELIVERY SHAFT, WITH THE BREAK REPORTED AT THE CATHETER. A SHEATH AND GUIDEWIRE WERE USED TO ASSIST WITH SAFELY REMOVING THE BALLOON PORTION FROM THE PATIENT¿S BODY, AND THE PROCEDURE CONTINUED WITH THE NEXT STEP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.