MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

Model Number	G23747
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	05/26/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product code: dre.Concomitant devices: phillips glidelight 14fr and 16fr.Cook lr-tss-13.0.Pma/510(k): k141148.
Event or Problem Description
It was reported that the patient was undergoing a lead extraction procedure to remove three leads implanted within chest (right atrium, right ventricle, and left ventricle) because if a badly infected implantable cardioverter-defibrillator (icd).The lead extraction procedure was performed 2 weeks after the infection was confirmed.Of the leads to be extracted, the left ventricular was extracted first using a philips glidelight 14fr.Afterwards, the right ventricular lead was removed using the glidelight 14fr, glidelight 16fr, and finished with the cook evolution rl 13fr with a cook steadysheath (lr-tss-13.0).During extraction of the right ventricle lead, a strong adhesion around the superior vena cava (svc) curve was noted.Both glidelight laser sheaths were unable to go through the svc, but the evolution 13fr and steady sheath did pass through the area.Blood pressure reportedly dropped as the evolution device advanced beyond the svc towards lead tip.In response to drop, pericardiocentesis was performed and an intra-aortic balloon pump was employed while the patient was placed on a percutaneous cardiopulmonary support system.Extraction was then resumed, with all the targeted leads extracted completely using evolution rl 13fr to complete the case.Doctor noted that he was not sure when they damaged the vessel during the procedure.An update from territory manager revealed that patient passed on june 1st due to bacteremia.The doctor said the reason of the death is bacteremia and stated that he was able to stop bleeding from the svc during the procedure.For this patient, his condition and infection was bad when the lead extraction was performed.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer (Section G): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• Manufacturer Contact: brian johnston ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 12027209
• Report Number: 2522007-2021-00019
• Device Sequence Number: 20024854
• Product Code: DRE
• UDI-Device Identifier: 10827002237473
• UDI-Public: (01)10827002237473(17)230731(10)N173494
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

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 Expiration Date: 07/31/2023
• Device Model Number: G23747
• Device Catalogue Number: LR-EVN-13.0-RL
• Device Lot Number: N173494
• 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: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2020
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Male