MAUDE Adverse Event Report: COOK VASCULAR INC LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	LR-EVN-11.0
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/24/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Blank fields on this form indicate the information is unknown or unavailable.The event is currently under investigation.
Event or Problem Description
Initially an icd system was implanted in 1996 from the left.This was followed by an icd exchange in 2002 and 2005.Due to a thrombotic subclavian v.Left in 2011 an icd system was implanted from the right side.Now the rv lead should be replaced due to over-sensing.After using a locking stylet and entering the vessel anonima v.With a byrd 8,5 it was difficult to enter the superior vena cava.Even up-sizing to 10.0, 11.5 and 13 could not solve the problem and pushing the byrd more distally.Every time the outer-sheet was kinking.After a switch to an evn 11 device, the passage was done and the evn got staked at the distal coil at the ventricle.During pulling, suddenly the patient's blood pressure dropped.Punction of the v.Femoralis left and volume could handle the blood pressure at first.The procedure was continued with evn and the lead came out.Following this, the blood pressure dropped again.The patient became hypotonic and there was a need for cpr.The patient entered a heart-lung machine.With a pigtail catheter the user facility saw a leakage at the upper svc.The user facility tried to stop the bleeding with a balloon nukleos and with an aortic stent but the stent could not be placed sufficiently due to the strong calcification and the patient died.Additional information requested; however, it was not provided by the reporter.
Additional Manufacturer Narrative
(b)(4).A review of the complaint history and device history record was conducted for the purpose of this investigation.The device was not returned for evaluation.No photographs of the device or images of the procedure were provided.Based on the event report, lr-evn-11.0, lr-pplbes-8.5, lr-pplbes-10.0, and lr-pplbes-13.0 devices were used in a lead extraction procedure in which the patient's blood pressure dropped because of a tear in the superior vena cava.As a result of the tear, the patient died.Comments in the complaint indicate that calcification was present at the site of the tear.The blood pressure drop occurred during use of the lr-evn device.No comments were made indicating the devices contained a nonconformity, did not function per their intended purpose, or were misused.Manufacturing records show no signs that the device contained a nonconformity.Because the device was not returned, no images of the devices were provided, and the lot numbers were not provided, the root cause of this complaint is unknown.Based on comments in the complaint report, the pacemaker leads had been implanted for a long period of time, and calcification was present at the site of the tear.These complications increase the likelihood of an adverse event during the lead extraction process, and the ifu details the risks of the procedure.While the complaint itself was confirmed through the customer's testimony, it is unknown if a cook device caused the vascular tears, or which device caused the event.No indication was given that a device nonconformity or misuse caused this complaint.Based on the available information, no root cause could be determined.
Event or Problem Description
Initially an icd system was implanted in 1996 from the left.This was followed by an icd exchange in 2002 and 2005.Due to a thrombotic subclavian v.Left in 2011 an icd system was implanted from the right side.Now the rv lead should be replaced due to over-sensing.After using a locking stylet and entering the vessel anonima v.With a byrd 8,5 it was difficult to enter the superior vena cava.Even up-sizing to 10.0, 11.5 and 13 could not solve the problem and pushing the byrd more distally.Every time the outer-sheet was kinking.After a switch to an evn 11 device, the passage was done and the evn got staked at the distal coil at the ventricle.During pulling, suddenly the patient's blood pressure dropped.Punction of the v.Femoralis left and volume could handle the blood pressure at first.The procedure was continued with evn and the lead came out.Following this, the blood pressure dropped again.The patient became hypotonic and there was a need for cpr.The patient entered a heart-lung machine.With a pigtail catheter the user facility saw a leakage at the upper svc.The user facility tried to stop the bleeding with a balloon nukleos and with an aortic stent but the stent could not be placed sufficiently due to the strong calcification and the patient died.Additional information requested; however, it was not provided by the reporter.

• Brand Name: LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5695469
• Report Number: 1820334-2016-00436
• Device Sequence Number: 16196644
• Product Code: DRE
• UDI-Device Identifier: 10827002465401
• UDI-Public: (01)10827002465401(17)161130(10)N116950
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2016

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 Catalogue Number: LR-EVN-11.0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2016
• Device Age: 29 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2016
• Supplement Report FDA Received Date: 09/16/2016
• 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
• Patient Age: 75 DA