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

Catalog Number LR-EVN-11.0

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown as this is from a journal article.(b)(4).Pma/510(k): k142301.This event is from a journal article.This event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Per journal article ,'materialization of ghosts: severe intracardiac masses after pacemaker lead extraction requiring immediate surgical intervention', thirteen years after 2-chamber pacemaker implantation, a (b)(6)-year-old patient was referred for pacemaker lead extraction because of pocket infection.Lead extraction was performed with an 11-fr.Evolution mechanical dilator sheath set in the operating theatre with cardio-pulmonary bypass standby.The intraoperative pre-interventional transesophageal echocardiography revealed no vegetations on the pacemaker leads.However, after complete extraction, an inhomogeneous highly mobile structure of 3.7 cm was seen in the right atrium, also referred to as ¿ghost¿.Sudden cardiac death and symptomatic pulmonary embolism were reported as potential sequels.Because of the high mobility of this big structure, the decision for acute surgical intervention on cardiopulmonary bypass was made.The structure was fragmented during extraction.Some fragments could be retrieved via an incision of the pulmonary artery; the majority were removed through a right atrial access and the tricuspid valve.The histological analyses described the ghost as organized thrombus without signs of infection.Lead vegetations with infected thrombotic material are possible causes for pulmonary embolism but can be degraded because of the high thrombolytic capacity of the pulmonary vascular bed.On the contrary, transvenous leads are known to cause chronic thrombotic processes leading to a fibrous or even calcified cover of the leads.The channel of one lead could be identified on the biggest fragment.Therefore, any degradation of this material is unlikely.The postoperative course was uneventful, and the patient fully recovered.Echo guidance during the primary procedure and a rapid surgical intervention are reasonable to extract mobile masses of significant size.References: le dolley y, thuny f, mancini j, et al.Diagnosis of cardiac device-related infective endocarditis after device removal.Jacc cardiovasc imaging 2010;3:673¿ 681.Novaro gm, saliba w, jaber wa.Images in cardiovascular medicine: fate of intracardiac.Lead vegetations after percutaneous lead extraction.Circulation 2002;106:e46.Candinas r, duru f, schneider j, luscher tf, stokes k.Postmortem analysis of encapsulation.Around long-term ventricular endocardial pacing leads.Mayo clin proc 1999;74:120 ¿125.Keywords lead extraction; ghost; lead vegetation; pocket infection; pacemaker lead (heart rhythm 2013;10:1826).Address for reprint requests and correspondence: dr martin andreas, md, mba, department of cardiac surgery, medical university of vienna, waehringer guertel 18-20, level 20a, 1090 vienna, austria.E-mail address: martin.Andreas@meduniwien.Ac.At.1547-5271/$ -see front matter © 2013 heart rhythm society.All rights reserved.Http://dx.Doi.Org/10.1016/j.Hrthm.2012.05.026.

Event Description

Journal article published in heart rhythm (december 2013).It was reported that thirteen years after 2-chamber pacemaker implantation, a 50-year-old patient was referred for pacemaker lead extraction because of pocket infection.Lead extraction was performed with an 11-f evolution mechanical dilator sheath set (cook medical, inc, (b)(4)) in the operating theatre with cardio- pulmonary bypass standby.The intraoperative pre-interventional transesophageal echocardiography revealed no vegetations on the pacemaker leads.However, after complete extraction, an inhomogeneous highly mobile structure of 3.7 cm was seen in the right atrium, also referred to as ¿ghost¿ (figure 1).Sudden cardiac death and symptomatic pulmonary embolism were reported as potential sequels.1,2 because of the high mobility of this big structure, the decision for acute surgical intervention on cardiopulmonary bypass was made.The structure was fragmented during extraction.Some fragments could be retrieved via an incision of the pulmonary artery; the majority were removed through a right atrial access and the tricuspid valve (figure 2).The histological analyses described the ghost as organized thrombus without signs of infection.Lead vegetations with infected thrombotic material are possible causes for pulmonary embolism but can be degraded because of the high thrombolytic capacity of the pulmonary vascular bed.On the contrary, transvenous leads are known to cause chronic thrombotic processes leading to a fibrous or even calcified cover of the leads.3 in this image, the ghost represents chronic thrombotic material with a high grade of fibrous tissue.The channel of one lead could be identified on the biggest fragment.Therefore, any degradation of this material is unlikely.The postoperative course was uneventful, and the patient fully recovered.Echo guidance during the primary procedure and a rapid surgical intervention are reasonable to extract mobile masses of significant size.References: 1.Le dolley y, thuny f, mancini j, et al.Diagnosis of cardiac device-related infective endocarditis after device removal.Jacc cardiovasc imaging 2010;3:673¿ 681.2.Novaro gm, saliba w, jaber wa.Images in cardiovascular medicine: fate of intracardiac lead vegetations after percutaneous lead extraction.Circulation 2002;106:e46.3.Candinas r, duru f, schneider j, luscher tf, stokes k.Postmortem analysis of encapsulation around long-term ventricular endocardial pacing leads.Mayo clin proc 1999;74:120 ¿125.Keywords lead extraction; ghost; lead vegetation; pocket infection; pacemaker lead (heart rhythm 2013;10:1826) address for reprint requests and correspondence: dr martin andreas, md, mba, department of cardiac surgery, medical university of vienna, waehringer guertel 18-20, level 20a, 1090 vienna, austria.E-mail address: martin.Andreas@meduniwien.Ac.At.Figure 2 figure 1 1547-5271/$ -see front matter © 2013 heart rhythm society.All rights reserved.Http://dx.Doi.Org/10.1016/j.Hrthm.2012.05.026 no new information has been received since the last report.

Manufacturer Narrative

A1: changed to 241017.B3: date of event is unknown as this is from a journal article.D2b: product code: dre.E1: customer: author: martin andreas.F10: patient code: thrombosis (2100), labeled.F10: device code: no code available (3191).G5: pma/510(k): k142301.H6: method code: changed to device discarded (4115).H6: conclusion code: changed to known inherent risk of device (22).No lr-evn device was returned to cvi.This complaint was issued due to literature review, from the department of cardiac surgery, medical university of vienna.The article was published in heart rhythm in december 2013.The device was not returned to cvi therefore a physical investigation of the device was not performed.The quality engineering department reviewed the provided article.A manufacturing failure/defect of the device could not be confirmed with the information provided.Adverse physiological response and pulmonary embolisms are known failure modes of this device.Pulmonary embolism is also listed as a potential adverse event in the instructions for use.This complaint will be monitored and trended through the cvi complaint handling and the post market surveillance processes.A risk assessment will be performed via a qera and documented in the complaint summary tab of trackwise.The dhr could not be reviewed as the lot number was unknown/not provided.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 contributed to a death or serious injury if a malfunction occurred.Attachment: [(b)(4)_ journal article_andreas_materialization of ghosts.Pdf].

• Brand Name: LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET
• Type of Device: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7966524
• MDR Text Key: 123802579
• Report Number: 2522007-2018-00023
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LR-EVN-11.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR