A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv), and a left ventricular (lv) lead due to bacteremia.Based on ct imaging, a previously placed stent near the entry site appeared to have tacked the leads to the vessel wall.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.To determine whether the leads had been tacked, each lead was manually pulled, and appeared free.Beginning with a spectranetics 14f glidelight laser sheath on the rv lead, the rv lead was removed without issue.However, when the glidelight was removed from the patient, uncontrolled bleeding was noted from the subclavian region.Interventions began immediately, including blood transfusions and successful repair of what was likely an extension of the perforation at the access site within the subclavian vein (mdr #3007284006-2023-00052).The decision was made not to remove the lv and ra leads, due to the amount of blood loss and the concern that the perforation would extend again.The physician attempted to unlock both llds from the lv and ra leads, but was unsuccessful.The lv lead/lld (mdr #3007284006-2023-00053) and the ra lead/lld (mdr #3007284006-2023-00054) were cut and capped and remained in the patient.The patient survived the procedure, with the plan to bring the patient back at a later date to attempt femoral snaring of the leads.This report captures the lld within the lv lead which was cut and capped and remained in the patient.
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A4): patient''s weight unk.H3): a portion of the lld was discarded, and a portion remained within the lv lead in the patient, thus no investigation could be completed.H6): lld cut/cap 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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