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

Model Number UNAVAILABLE

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

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

Event Date 05/19/2020

Event Type  Death  

Manufacturer Narrative

Patient date of birth unavailable.Patient weight unavailable.Device model number, lot number, expiration date and udi unavailable.Device 510k number unavailable because model number unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove three leads: a right ventricular (rv), right atrial (ra) and left ventricular (lv) lead due to endocarditis from candida fungemia.The patient had an extensive medical history including long term steroid use.Vegetations were found to be attached to pacemaker leads, the largest up to 4.5 cm, mainly located in the ra and tricuspid valve regions, and a ct performed on (b)(6) 2020 demonstrated evidence of pulmonary septic emboli as well as bilateral effusions.Prior to the procedure, it was reported that an angiovac device was used to extract as much of the vegetation as possible.The three leads were extracted successfully.The lv lead was extracted using traction only.The rv lead was then extracted with use of a spectranetics lead locking device (lld) to act as traction platforms and a tightrail rotating dilator sheath.The tightrail device was used from the subclavian region to the innominate/svc region and the rv lead then released.The ra lead was removed with use of an lld partway down the ra lead (due to angle of lead), suture as additional traction, and the tightrail, again only being used to the innominate/svc region when the ra lead released.Approximately 15 minutes after the extraction, the patient's blood pressure began to drift downward.Transesophageal echocardiography (tee) and fluoroscopy confirmed an effusion.Rescue efforts began immediately including pericardiocentesis, sternotomy and bypass.An rv apex tear was detected and repaired.Although the patient survived the procedure, it was communicated to the rep on (b)(6) 2020 that the patient suffered multiple strokes and passed away on (b)(6) 2020.There was no alleged malfunction of any spectranetics devices used in the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE 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: 10113051
• MDR Text Key: 193582500
• Report Number: 1721279-2020-00114
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR