[184073898]
Patient weight unavailable. Mode#, lot#, catalog# and unique identifier (udi#) unavailable. Device manufacture date unavailable because lot# is unavailable. Injury to the coronary sinus is a known risk of complication during the procedure when using the lld; however in addition, an injury to the left marginal artery was reported as well. It was reported that adhesions (surrounding the lv lead) in the coronary sinus were present, and that due to mechanical traction, the injury was created in both vessels (the coronary sinus and the neighboring artery, the left marginal), due to the adhesions. It was reported that the physician used "a stitch" to tie off both the coronary sinus and the left marginal artery. No other conclusions code accurately captured this event.
Patient Sequence No: 1, Text Type: N, H10
[184073899]
A lead extraction procedure commenced to remove 2 right atrium (ra) leads, 2 left ventricle (lv) leads and one right ventricle (rv) lead due to bacteremia. One of the two ra leads was targeted for extraction first. A spectranetics 12f glidelight and spectranetics ez lld successfully removed the lead without any complications. Next, one of the two lv leads was targeted for extraction. During this attempt, an ez lld using only traction was used to remove the lead, without success. After this failed attempt the physician elected to move on to extract the rv lead. This was done successfully using a spectranetics 16f glidelight and ez lld. The physician moved back to the lv lead that was previously attempted for extraction. This attempt at removal was successful using an ez lld using only traction. Next, they tried to extract the second lv lead. The physician advanced a spectranetics 12f glidelight, a spectranetics ez lld and suture, used for additional traction, into the coronary sinus. The extraction began by using laser application with the 12f glidelight in the coronary sinus to break up the adhesions surrounding the lv lead. At this time, traction and counter traction were used without laser application and the lead tip released and the entire lead was removed. After the entire lv lead was removed the patients blood pressure started to drop. Chest compression were started. At this time the fifth and final lead in the ra was removed with an ez lld using traction only, while chest compressions were being administered. A surgeon and surgical team quickly intervened. A sternotomy along with by bypass were used; tears were discovered in the coronary sinus and from the rep's understanding, the left marginal artery. The tears in the coronary sinus and left marginal artery were successfully repaired. There was no alleged malfunction of any spectranectics devices. The physician stated he felt the tears were caused by mechanical traction and adhesions present in the area. This report is being submitted because the lld was present within the lv lead and was used as a traction platform.
Patient Sequence No: 1, Text Type: D, B5