MAUDE Adverse Event Report: COOK VANDERGRIFT, INC. EVOLUTION RL MECHANICAL DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION

Model Number	UNKNOWN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, not applicable or not available.The reported event was discovered in a journal article/study by merit medical systems inc, specific to a lead extraction bulldog lead extender.Merit medical then forwarded the information to cook medical.The event is currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
The following information was forwarded by merit medical systems to cook medical regarding a journal article/study titled, "transvenous extraction of pacemaker and defibrillator leads and the risk of tricuspid valve regurgitation".Description as reported by merit medical systems: "this study describes the scope of significant tricuspid valve (tv) injury with increase in tricuspid regurgitation by using of transvenous lead extraction (tle) method for lead removal.Study was conducted on qualifying 208 patients.Perfecta electrosurgical dissection sheath and evolution rotating dilator sheath were used, and evaluations were observed with transesophageal echocardiography (tee) which concluded with significant increase in tricuspid regurgitation (tr).Of the 208 patients, significant increase in tr was observed in 24 patients after extraction which resulted in longer post extraction hospital stay.As for the mechanisms of acute tri observed in 24 patients, 7 patients showed tee data suggesting tv injuries.In 1 patient without evidence of tv injury, aggravation of left ventricular.Study showed that lead age was identified as an independent predictor in multivariate analysis as well.".

• Brand Name: EVOLUTION RL MECHANICAL DILATOR SHEATH SET
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT, INC.; 1186 montgomery lane; vandergrift PA 15690 6065
• Manufacturer (Section G): COOK VANDERGRIFT, INC.; 1186 montgomery lane; vandergrift PA 15690 6065
• Manufacturer Contact: kimberly platt ; 1186 montgomery; vandergrift, PA 15690-6065 ; 7248458621
• MDR Report Key: 24888702
• Report Number: 2522007-2026-00010
• Device Sequence Number: 21306482
• Product Code: DRE
• UDI-Device Identifier: 00827002465428
• UDI-Public: 00827002465428
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2026

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK EVOLUTION RL ROTATING DILATOR SHEATH; COOK PERFECTA ELECTROSURGICAL DISSECTION SHEATH; GLIDELIGHT EXCIMER LASER SHEATH; SLS II EXCIMER LASER SHEATH; TEE PROBE; TIGHTRAIL ROTATING DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown