A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead due to non function.The patient had a baseline pericardial effusion present pre-procedure.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Multiple spectranetics devices (11f tightrail sub-c rotating dilator sheath, 13f tightrail rotating dilator sheath, glidelight laser sheath) were used to extract the ra and rv leads.The rv lead was firmly adhered within the vessel; however, the ra and rv leads were successfully removed.During attempted extraction of the lv lead, several attempts were made but were unsuccessful.The physician elected to cut the lv lead/lld near the pocket and abandoned it, with no attempt to unlock the lld from the lead.A short time after the lead extraction portion of the procedure was completed, the baseline pericardial effusion worsened and cardiac tamponade resulted.Rescue efforts began, including pericardiocentesis, and the patient stabilized without further accumulation of fluid throughout the remainder of the case.A re-implantation of new ra, rv, and lv leads was completed, and the patient was transferred to the post anesthesia care unit (pacu).Later, the patient had a cardiac arrest that resolved with continuous aspiration of pericardial fluid.Patient was returned to the operating room, and labs showed an acute and severe coagulopathy.A sternotomy was performed and three perforations were discovered: a 2 cm longitudinal perforation on the posterior aspect of the innominate vein (mdr #1721279-2022-00190), a small perforation in the right atrium and a perforation to the obtuse margin, near the coronary sinus (mdr #1721279-2022-00192).The distal tip of the lv lead was noted to be extruding from a coronary vein (near the coronary sinus, observed outside the heart wall); the lv lead was firmly adhered to the vein, just proximal to the lv lead''s distal tip.Repairs to the perforations were completed; however, the patient could not be weaned off the pump and the decision was made to implement a do not resuscitate (dnr) order and the patient expired.This report captures the lld providing traction to the ra lead when an ra perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.Although the patient died, the death has been captured in mdr #1721279-2022-00190.
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Device evaluated by mfr: the device was discarded, thus no investigation could be completed.Cardiac perforation 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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