A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv), and a left ventricular (lv) lead due to bacteremia.Prior to the procedure, a small effusion was noted, and existing lead vegetation was removed.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The ra and rv leads were extracted successfully.Using a spectranetics 16f glidelight laser sheath to remove the lv lead, advancement was made to just under the clavicle.The lv lead pulled free and the existing effusion was noted to have grown; however, the patient remained stable.Due to the increased effusion that was detected after lv lead removal, a coronary sinus (cs) perforation was suspected with no intervention performed at that time.The procedure was completed and the patient survived.Later that evening a pericardiocentesis was performed to draw off blood that had accumulated in the pericardial sac, and the patient responded well to the intervention.However, it cannot be confirmed whether the lld within the lv lead caused or contributed to the suspected cs perforation.This report is being submitted conservatively for the lld present within the lv lead and a perforation was suspected, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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A4): patient weight unk.D4): device serial number unk.H3): device was discarded, thus no investigation could be completed.H6): perforation of vessels is a known risk of complication with use of the lld.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.
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