MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 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); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/28/2022

Event Type  Death  

Manufacturer Narrative

Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk.Investigation of this event is in process.A supplemental mdr will be submitted when the investigation has been completed.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 right atrial (ra) and a right ventricular (rv) lead due to non function (the leads had been implanted over 30 years).In addition, the patient had hypertrophic cardiomyopathy (hocm), confirmed thick septum, and contributing to the heart tissues being friable (fragile).Pre-procedure: ra lead had been implanted but over time, the ra lead tip had pulled away from the ra and was positioned just distal from the innominate/svc junction.Extensive scar tissue was present from the ra (where it was first implanted) and extended to the ra lead tip.The ra was inverted due to the pulling of the scar tissue.The tip of the ra lead was pointing straight downward, which the physician thought indicated that the ra lead tip was free.Instead, scar tissue was adhering the lead tip all the way down to the ra, where the tip was first implanted.The lead had been pulled up to the pocket, and had extensively scarred into the lateral wall from where the tip was located just distal to the innominate svc junction, all the way through the innominate vein.Spectranetics lead locking devices were inserted into each lead to provide traction.The physician used multiple spectranetics devices (13f tightrail sub-c rotating dilator sheath, 14f glidelight laser sheath, 13f tightrail long rotating dilator sheath) to attempt ra lead extraction.The 13f tightrail long device reached the tip of the ra lead; no tool was used past the innominate/svc junction, where the ra lead tip was located.With traction, the ra lead was removed; however, the patient's blood pressure dropped and did not recover.Rescue efforts began, including pericardiocentesis, rescue balloon, and ultimately sternotomy, to gain better access to the injury site.A large (described as massive) ra perforation was discovered, along with a perforation to the right coronary artery (rca) (mdr #1721279-2022-00204).An additional perforation was discovered in the innominate and innominate/superior vena cava (svc) regions (mdr #1721279-2022-00205), where the lead was deeply scarred in the vasculature.It was thought that the 13f tightrail (long) device, the last one in use in the area of the perforation, was likely tamponading the injury while traction was being applied in the attempt to free the ra lead.Repairs were completed, the rv lead was removed, and patient survived the procedure.However, patient died 3 days later, on (b)(6) 2022.This report captures the lld providing traction to the ra lead when the ra/rca perforations occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Event Description

Further information received on 09dec2022 confirmed injury location was the right atrium (ra), not the right coronary artery (rca) as reported in the initial mdr.

Manufacturer Narrative

B5/g3): additional information was provided by the physician on 09dec2022.H6): correction: hecc code 2135, listed in the initial mdr, is no longer applicable.Hecc code 2513 remains accurate.After completion of investigation, conclusions code 22 has been populated.Cardiac perforation 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.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15839653
• MDR Text Key: 304079981
• Report Number: 1721279-2022-00204
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 4024 RV ICD LEAD.; MEDTRONIC 4058M RA PACING LEAD.; SPECTRANETICS 13F TIGHTRAIL LONG DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICE.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Death
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White