Description of Event or Problem · 0
THE PATIENT WAS 73 YEARS OLD MALE AND CRTD HAD BEEN IMPLANTED FOR 14YEARS AND LL MONTHS. THE TIP OF LV LEAD WAS DISLODGED AND BACK TO CS OSTIAL. SINCE LV HAD NOT BEEN ABLE TO BE PACED AND IT HAD BEEN OBSERVED THE HEART FAILURE GOT WORSE, PROCEDURE WAS IMPLEMENTED FOR THE PURPOSE THAT THE DISLODGED LV LEAD WOULD BE REMOVED, AND NEW LV LEAD WOULD BE IMPLANTED. AND, THE PLAN WAS THAT RA LEAD AND RV LEAD WOULD BE MAINTAINED AND CONTINUED TO BE USED IF POSSIBLE. AROUND 10:50 THE ADHESION WAS BETWEEN LEADS, AND IT WAS DETERMINED THAT ONLY LV LEAD WOULD NOT BE ABLE TO BE REMOVED BY SIMPLE TRACTION REMOVAL. 10:05 LLD EZ WAS INSERTED INTO LV LEAD BUT IT COULD NOT REACH TO THE TIP OF THE LEAD. LOCKED THE TIP IN THE RIGHT ATRIUM (RA). 11:09 12F GLIDELIGHT WAS USED TO DECORTICATE THE LV LEAD. THERE WAS ADHESION BETWEEN LEADS ON THE WAY, BUT IT COULD BE ADVANCED WITHOUT BIG DIFFICULTY. WHEN THE TIP OF SHEATH ADVANCED AROUND SVC/RA JUNCTION, THE TIP OF LV LEAD WAS DISLODGED FROM THE TISSUE AND THE LEAD COULD BE RETRIEVED INTO THE SHEATH, COMPLETING THE LV LEAD REMOVAL (AROUND 11:15). AFTERWARD, A GUIDEWIRE WAS INSERTED INTO THE LASER SHEATH AND STARTED IMPLANTATION OF NEW LV LEAD. AROUND 12:00 NEW LV LEAD WAS IMPLANTED, AND DURING MAKING CONFIRMATION, A DECREASE OF BP WAS OBSERVED, LIKE 110(PRE) -> 60S(POST), AFTER THAT IT WAS SHOWED THE SLOW TREND TO DECREASE. SINCE PERICARDIA, EFFUSION WAS OBSERVED, IT WAS DETERMINED TAMPONADE. THEN, PERICARDIA! DRAINAGE WAS ATTEMPTED BUT THERE WAS NOT MUCH IMPROVEMENT ON BP. AROUND 12:40 PCPS WAS INTRODUCED AND THE HEMODYNAMICS BECAME STABLE. AROUND 13:30 IABP WAS INTRODUCED. AFTERWARD, BECAUSE THE SIGNIFICANT DECREASE OF HEMORRHAGE WAS NOT CONFIRMED, IT WAS DETERMINED THAT THORACOTOMY WITH REPAIR PROCEDURE BY SURGEON. AROUND 14:00 DURING THE THORACOTOMY BY CARDIAC SURGEON, TEAR WAS CONFIRMED A PLACE A BIT FROM CS OSTIAL AND IT WAS REPAIRED. FURTHER INFORMATION OBTAINED (B)(6) 2023: THE GLIDELIGHT WAS REMOVED FROM THE PATIENT AT APPROXIMATELY 11:18. ALL DEVICES USED FOR IMPLANTATION OF NEW LV LEAD WERE FROM OTHER MANUFACTURERS. THE PATIENT'S HEMODYNAMICS DID NOT CHANGE UNTIL APPROXIMATELY 12:00. (B)(6) PHYSICIAN ASSESSMENT (B)(6) 2023: THE LLD NEVER MADE IT DOWN TO THE LV LEAD TIP. AS SOON AS THE LEAD ON LEAD BINDING WAS RESOLVED, THE LV LEAD FREED. IT CANNOT BE DETERMINED WHEN THE INJURY OCCURRED; HOWEVER IT DID NOT APPEAR THAT IT WAS IMMEDIATELY AFTER LEAD REMOVAL. THE PATIENT'S BLOOD PRESSURE DROPPED AND PERICARDIAI EFFUSION WAS NOTED AFTER IMPLANTATION OF THE NEW LV LEAD. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).