LLD EZ LEAD LOCKING DEVICE

Additional Manufacturer Narrative

A2) PATIENT DATE OF BIRTH - NOT AVAILABLE FROM FACILITY. A3B) PATIENT GENDER - NOT AVAILABLE FROM FACILITY. A4) PATIENT WEIGHT - NOT AVAILABLE FROM FACILITY. A5) PATIENT ETHNICITY - NOT AVAILABLE FROM FACILITY. B6/B7) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY - 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, CARDIAC TAMPONADE 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) AND TWO RIGHT VENTRICULAR (RV) LEADS DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, COOK MEDICAL 11F EVOLUTION SHORTIE, COOK MEDICAL 11F EVOLUTION, COOK MEDICAL 13F EVOLUTION, ONE OF THE RV LEADS WAS SUCCESSFULLY REMOVED. NEXT, TARGETING THE RA LEAD, THE RA AND RV LEADS WERE FOUND TO BE INTERTWINED AND ADHERED AROUND THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION. USING THE SAME TOOLS, ALONG WITH A COOK MEDICAL STEADYSHEATH, THE RA LEAD FRACTURED AT THE ENTANGLEMENT SITE; THEREFORE, THE REMAINDER OF THE RA LEAD WAS SNARED VIA A FEMORAL APPROACH. DURING THIS TIME, THE PATIENT'S BLOOD PRESSURE DROPPED, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE FROM AN INJURY (UNKNOWN LOCATION). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, AND THE PATIENT STABILIZED. THE EXTRACTION PROCEDURE CONTINUED ON THE REMAINING RV LEAD USING THE 13F EVOLUTION AND 13F TIGHTRAIL; HOWEVER, ADVANCEMENT BEYOND THE TRICUSPID VALVE WAS UNSUCCESSFUL. THE RV LEAD WAS REMOVED VIA SURGICAL THORACOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ PROVIDING TRACTION ON THE RA LEAD WHEN THE CARDIAC TAMPONADE OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.