MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD EZ LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 02/15/2024

Event Type  Death  

Manufacturer Narrative

A2): patient''s date of birth unk.H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels and death are known risks 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.

Event Description

A lead extraction procedure commenced to remove a left ventricular (lv) lead due to non function.A right atrial (ra) and a right ventricular (rv) leads were present in the patient as well, but were not targeted for extraction.The patient was pacemaker dependent with end stage cardiomyopathy, so prior to the procedure, a temporary pacemaker was inserted via a femoral approach.In addition, calcium was noted in the pocket prior to lead extraction.A spectranetics lld ez lead locking device (lld ez) was inserted into the lv lead, with silk suture used as well, to provide traction.Beginning with a spectranetics 14f glidelight laser sheath, advancement was made to the mid-innominate region where progress stalled.Next, a spectranetics 13f tightrail sub-c rotating dilator sheath was used, making progress to the curve of the superior vena cava (svc).Switching back to the 14f glidelight and the glidelight''s outer sheath, advancement was made to the coronary sinus os (cs os).While applying moderate traction with use of the lld ez, the lv lead began to retract out of the cs, and was extracted, with considerable amounts of scar tissue noted on the lead.The lead and glidelight were removed from the patient; however, a small effusion was detected via transesophageal echocardiography (tee) and fluoroscopy revealed the borders of the heart were in question.The patient''s blood pressure was slowly dropping, and rescue efforts began, including pericardiocentesis, sternotomy, and cell saver.A distal, lateral cs wall perforation was discovered and intervention began.During repair, the capillaries and blood vessels began to swell to a point that when the repair was complete and the temporary pacemaker was removed, the right ventricle of the heart did not function.The patient did not survive.This report captures the lld ez providing traction within the lv lead when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: LLD EZ LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18861766
• MDR Text Key: 337180491
• Report Number: 3007284006-2024-00047
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)251215(10)FLP23M13A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP23M13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 4193 LV PACING LEAD.; MEDTRONIC 5076 RA PACING LEAD.; MEDTRONIC 6947 RV ICD LEAD.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White