A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non-function.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics tightrail sub-c rotating dilator sheath, then switching to a 13f spectranetics tightrail rotating dilator sheath on the ra lead, the lead was removed.However, after approximately 30 seconds, an effusion was detected on transesophageal echocardiography (tee) and the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon, sternotomy, and bypass.A posterior superior vena cava (svc) perforation, a few cm above the svc/ra junction was discovered and repaired (mdr#: 3007284006-2024-00014).The remaining rv lead (containing an lld #2) was found to be heavily fibrosed into the svc wall, and it was determined the lead would not be removed.An attempt was made to unlock the lld #2 from the rv lead, but was unsuccessful; therefore, the rv lead/lld were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld #2 within the rv lead which was cut and capped, and remained in the patient.
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H3): a portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.H6): lld cut and 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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