LLD EZ LEAD LOCKING DEVICE

Additional Manufacturer Narrative

A2) PATIENT DATE OF BIRTH - NOT AVAILABLE FROM FACILITY. A4) PATIENT WEIGHT - NOT AVAILABLE FROM FACILITY. D4/H4) THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. H3) THE LLD EZ WAS DISCARDED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. H6) PER IFU, PERFORATION IS LISTED AS A POTENTIAL ADVERSE EVENT WITH USE OF THE LLD DEVICE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

Description of Event or Problem

A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT WITHIN THE PATIENT, BUT NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) AND COOK MEDICAL NEEDLE'S EYE SNARE WERE INSERTED ONTO THE RA LEAD TO PROVIDE TRACTION. BEGINNING WITH A COOK MEDICAL 11F EVOLUTION SHORTIE, ADVANCEMENT WAS MADE TO THE INNOMINATE VEIN, AND SWITCHED TO A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH. PROGRESS WAS MADE TO THE SUPERIOR VENA CAVA (SVC), THEN A COOK MEDICAL 10F BYRD DILATOR SHEATH WAS UTILIZED, AND THE RA LEAD WAS REMOVED. RE-IMPLANT OF THE RA LEAD WAS INITIATED; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND MEDICATION. THE PATIENT STABILIZED, THE RE-IMPLANT WAS COMPLETED AND THE PATIENT SURVIVED THE PROCEDURE. THE EXACT BLEEDING SITE COULD NOT BE IDENTIFIED, BUT BELIEVED TO BE AN INJURY TO THE MIDDLE CARDIAC VEIN (MCV) FROM TRACTION FORCES DURING EXTRACTION. THIS REPORT CAPTURES THE LLD EZ PROVIDING TRACTION ON THE RA LEAD WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.