NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER

Description of Event or Problem

IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE RIGHT COMMON CAROTID ARTERY USING THE NANOCROSS ELITE BALLOON WITH EMBOLIC PROTECTION (SPIDER) IN A PATIENT WITH CAROTID ARTERY DISEASE AND A TARGET LESION DESCRIBED AS CALCIFIED PLAQUE AND SOFT TISSUE PLAQUE (LESION LENGTH 20 MM), THE BALLOON BURST DURING THE PROCEDURE AT AN UNKNOWN PRESSURE. IT WAS REPORTED THAT THE BALLOON DETACHED FROM THE BALLOON SHAFT AT THE TARGET LESION AND REQUIRED REMOVAL WITH A SNARE, AND ALL FRAGMENTS WERE RETRIEVED. IT WAS REPORTED THAT A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

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.