MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

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

Patient Problems Death (1802); Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

Patient's weight unavailable.

Event Description

A lead extraction procedure commenced to remove two right ventricular (rv) leads and one coronary sinus (cs) lead due to pocket infection and mrsa.Pt had a prior sternotomy (reason believed to be a previous coronary artery bypass graft) and a small pericardial effusion was noted pre-procedure.Spectranetics lead locking devices (lld's) were present in one of the rv leads and in the cs lead to provide traction.Other traction platforms were used as well: cook medical one-tie devices on all three leads, along with the use of a cook medical liberator device and suture on one of the rv leads, all to provide traction.The physician began working to extract one of the rv leads, and with a spectranetics 16f glidelight laser sheath, progress stalled just under the clavicle.A spectranetics 13f tightrail sub-c device progressed to the patient¿s midline.The tightrail sub-c device was then used on the cs lead, and progress was made to the patient's midline as well.Then the physician used the 16f glidelight device again on the rv lead, and progress stalled just before the proximal coil in the distal innominate/proximal svc region.The physician then began to work to extract the other rv lead with the 16f glidelight, and this lead was removed successfully.The cs lead was targeted for removal next, and using the 16f glidelight, progress stalled in the innominate region.The physician then used a spectranetics 13f tightrail device to progress to the cs where it advanced no farther; manual traction was then used to remove the cs lead, with just the tip of lead remaining in the patient's cs.Bleeding from the entry site at the pocket was noted, and was significant enough to warrant transfusion.The patient's blood pressure began dropping, with small growth in cardiac effusion noted.Surgical backup was called and rescue efforts began, including use of a rescue balloon, in which blood pressure rose slightly with its use.The surgical team decided the patient was not a candidate for rescue or open chest removal of the remaining rv lead.A spectranetics 13f tightrail was introduced onto this remaining rv lead, with very little progress made.A 13f cook evolution device was introduced, with very little advancement in the vasculature.The patient's blood pressure then dropped substantially.The rescue balloon was utilized again, with no change in blood pressure.Cpr began; a pericardiocentesis was unsuccessful, and ultimately all rescue efforts performed were unsuccessful.The patient did not survive.The autopsy report revealed a 4.5 cm laceration near the coronary sinus on the posterior rv epicardium, and a lead tip perforation on the rv posterior wall.This report is being submitted to capture the lead tip perforation on the rv posterior wall; it could not be determined which rv lead caused the perforation, and the lld device was used as the traction platform in one of the rv leads.

Manufacturer Narrative

B2): outcomes now reflected as "required intervention" instead of "death" (captured in the initial mdr).G3): manufacturer became aware of the need for supplemental correction mdr on 03 aug 2021.H1): type of reportable event corrected to "serious injury".H3): the device was discarded, thus no investigation could be completed.H6): heic code 1802 not applicable for this report; hecc code 2513 remains applicable for this event.Postmarket surveillance performed a record review and discovered that two mdr''s (1721279-2020-00037 and 1721279-2020-00038) were submitted for "death" for the same patient.This duplicated the patient''s death, which trended more deaths than actually occurred.This supplemental mdr is being submitted to change "death" to "injury", accurately reflecting the event and avoiding "death" duplication.Mdr #1721279-2020-00038 will remain unchanged.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9723262
• MDR Text Key: 179921002
• Report Number: 1721279-2020-00037
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)211214(10)FLP19M12A
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP19M12A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK MEDICAL LIBERATOR DEVICE.; COOK MEDICAL ONE-TIE DEVICES.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICE.; ST. JUDE 1156 LV PACING LEAD.; ST. JUDE 1888 RV PACING LEAD.; ST. JUDE 7120 RV ICD LEAD.; SUTURE MANUFACTURER UNKNOWN.
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 59 YR