KYPHON KIS

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOP LASTY FOR BONE METASTASIS. IT WAS REPORTED THAT BALLOONS WERE INFLATED AT L5 LEVEL AFTER OSTEOCOOL ABLATION. BOTH BALLOONS POPPED. THE BALLOON ON THE PATIENTS RIGHT SIDE RUPTURED IN THE VERTEBRAL BODY AND A PORTION OF BALLOON WITH DISTAL RADIOPAQUE MARKER REMAINED WITHIN THE VERTEBRAL BODY. PHYSICIAN COMPETED THE PROCEDURE WITH CEMENT AUGMENTATION AT THIS LEVEL. THE BALLOON RUPTURED/POPPED AND THE RADIOPAQUE MARKER FROM THE BALLOON WAS LEFT INSIDE OF THE VERTEBRAL BODY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

RADIOGRAPHIC IMAGE REVIEW: MULTILEVEL LATERAL X-RAY, CEMENT PRESENT IN VERTEBRAL BODY. MULTIPLE SMALL NUMBERS CONSISTENT WITH RUPTURED BALLOON PRESENT IN VERTEBRAL BODY. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.