A lead extraction procedure commenced to remove two right ventricular (rv, models 7120q and 6931) leads due to non-function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into both leads to provide traction.Beginning with a spectranetics 16f glidelight laser sheath on the 7120q lead, progress was made through the innominate with ease.Before entering the superior vena cava (svc) region, surgical backup was requested and confirmed, and the procedure continued.Advancement continued down the svc, through the svc/ra junction, where significant lead on lead binding was encountered.While the glidelight was in the ra, an effusion was detected via echo imaging.Rescue efforts began, including rescue balloon, pericardiocentesis, and sternotomy, since the echo revealed large amounts of blood.A 2-3 inch svc lateral wall perforation was discovered (mdr #3007284006-2024-00048).The repair of the svc perforation proved to be difficult, but was completed using pericardium tissue.Another perforation was discovered in the innominate region, and the innominate vein was ligated.At that time, the decision was made to abandon the two rv leads.There was no attempt to unlock the llds from the leads, so 7120q rv lead/lld and 6931 rv lead/lld (mdr #3007284006-2024-00050) were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld ez within the 7120q rv lead, which was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.
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B7): other relevant history unk.D4): device lot number, expiration date unk.Partial udi populated.H3): a portion of the device was discarded and a portion of the device remained in the patient, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.H6): although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.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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