MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS VISISHEATH DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	501-016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	10/29/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient's weight unavailable.Device lot number and expiration date unavailable device manufacture date unavailable because lot number unavailable.(b)(4).Rescue intervention first commenced when the innominate tear occurred and the visisheath device was in use.It was reported that the repair to the innominate injury was successful and the patient survived the lead extraction portion of the procedure.However, it cannot be ruled out whether the innominate injury (that occurred while the visisheath was in use)could have been a contributing factor in the patient's death.In the spectranetics instructions for use (ifu) for this device, under 6.Adverse events-potential adverse events, it lists, in part, "laceration or tearing of vascular structures or the myocardium".Additionally in the ifu under 9.2.10 clinical technique - precaution, it instructs "when advancing a sheath around a bend, keep the point of the sheath's beveled tip oriented toward the inside of the bend".During the procedure, the philips representative reportedly noted that the visisheath's bevel was lateral instead of medial and informed the physician of this.At that time the patient's blood pressure dropped.Because of this above information provided.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to fracture.A left ventricular (lv) lead was present within the patient but not targeted for extraction.Implant duration for rv and lv was approximately 16 years.Goal was to remove rv lead, re implant new rv lead, then patient was to have mitral valve and aortic valve replacement the next day.First, a spectranetics lead locking device (lld) was used within the rv lead; however the lld would not go down the lead because of the lead fracture in the subclavian region.The physician then tried a different size of lld.This lld went in and locked as intended, but was not large enough to snug the walls of the rv lead.It appeared to work for a short time while initially lasing, but then the lld pulled out of lead.The physician decided to use suture instead, to provide the traction for lead removal.He began with a spectranetics 14f glidelight laser sheath and met stalled progression halfway down between the pocket and the superior vena cava (svc) (likely in innominate region).Then he switched devices to a spectranetics 11f tightrail sub-c rotating dilator sheath and progressed an additional 2 cm down the vasculature and met stalled progression.Then a 16f glidelight laser sheath was used; however, progress stalled in the same area as 11f sub-c.Then a spectranetics 13f tightrail sub-c was used, which progressed an additional 2-4 cm in the innominate region.A large 43 cm spectranetics visisheath dilator sheath, along with use of a 16f glidelight was used to dissect in the area and a little more progress was made.The philips representative present in the procedure noticed that the bevel of the visisheath was lateral instead of medial, and informed the physician.At that time the patient''s blood pressure dropped.Rescue efforts commenced, including rescue balloon, which did stabilize the patient's blood pressure.A sternotomy commenced and an innominate vein tear was discovered and repaired.The surgeon then decided to use the 14f glidelight again to attempt removal of the rv lead (while the chest was open), but encountered stalled progression in the same area.The physician upsized to a 16f glidelight device and lased for one second, then used the glidelight as a manual sheath and made no progress.At that time, the physician used a long tweezer to puncture into the area of the innominate vein and created a tear, then pulled calcification out through the innominate, and then ultimately pulled the rv and lv lead out through the innominate tear, then repaired the innominate tear (no spectranetics devices were in use to create the second innominate tear that was reportedly caused by the tweezers alone).Then pocket was then closed.It was thought that the surgeon then commenced to performing the mitral and aortic valve replacements.It is unknown at this time whether an rv lead was re-implanted.The patient survived the lead extraction procedure.On (b)(6) 2020, the philips rep informed the manufacturer that he heard the patient died during the procedure when they were working on the mitral valve replacement, (b)(6)2020.There was no alleged malfunction of any spectranetics devices in use during the lead extraction procedure.

• Brand Name: SPECTRANETICS VISISHEATH DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10879980
• Report Number: 1721279-2020-00239
• Device Sequence Number: 14440524
• Product Code: DRE
• UDI-Device Identifier: 00813132020378
• UDI-Public: 00813132020378
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 501-016
• Device Catalogue Number: 501-016
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR