MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION

Catalog Number LR-EVN-11.0-RL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.Product code: dre.Rpn: lr-evn-11.0-rl.Initial reporter: author of article-mihran martirosyan, address: erasmus mc, westzeedijk 353, rotterdam, netherlands.Pma/510(k): k141148.The 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: "left diaphragmatic hemiparesis an unexpected complication of transvenous lead extraction", 'after a lead extraction, using a mechanical dilator sheath equipped with rotating threaded tip.A (b)(6) man (noncompaction cardiomyopathy, implantable cardioverter-defibrillator implantation) was referred for extraction of the malfunctioning right ventricular leads.An evolution mechanical dilator sheath was used to dissect adhesions via superior approach.The whole systems were successfully extracted and new systems were implanted directly thereafter.The patient developed dyspnea and sleeping disorders gradually during the first 4 months of follow-up.Left hemidiaphragm paralysis was diagnosed.Due to severe dyspnea the patient underwent a successful surgical plication of diaphragm 1 year later.At follow-up visit after 2 years, the clinical symptoms improved; the right hemidiaphragm showed normal function while the left side displayed no movement on check x-ray.This paralysis is suggested to be related to the damage of the left phrenic nerve during the process of dissecting adhesions in those parts of the left subclavian vein that run in the close vicinity of the nerve.' from the department of clinical electrophysiology, erasmus medical center, university medical center, rotterdam, the netherlands; department of heart failure/heart transplantation, erasmus medical center, university medical center, rotterdam, the netherlands; and the department of cardiothoracic surgery, erasmus medical center, university medical center, rotterdam, the netherlands.The authors have reported that they have no relationships relevant to the contents of this paper to disclose.All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors¿institutions and food and drug administration guidelines, including patient consent where appropriate.For more information, visit the jacc: clinical electrophysiology author instructions page.Manuscript received december 19, 2016; revised manuscript received january 24, 2017, accepted february 2, 2017.Jacc: clinical electrophysiology vol.3 , no.1 0 , 2017 ª 2017 the authors.Published by elsevier on behalf of the american college of cardiology foundation.This i s an open access article under the cc by -nc-nd license ( htt p: / / creativ e commons.Org /lic enses / by - nc - nd /4.0/ ).Issn 2405 - 500 x.

Manufacturer Narrative

Section b3-date of event: unknown.Section d2b-product code: dre.Section d-rpn: lr-evn-11.0-rl.Section e-initial reporter: author of article-mihran martirosyan, address: erasmus mc, westzeedijk 353, rotterdam, netherlands.Sectiong5-pma/510(k): k141148.Section h6: patient code 1 - uf/importer: dyspnea (1816).Section h6: device code desc 1 - adverse event without identified device or use problem (2993).Section h6: ec method code desc - 1: device not accessible for testing (4117).Section h6: ec method code desc - 2: device not returned (4114).Section h6: ec results code desc - 1: no findings available (3221).Section h6: ec conclusions code desc - 1: cause not established (4315).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 Description

Per journal article: "left diaphragmatic hemiparesis an unexpected complication of transvenous lead extraction", 'after a lead extraction, using a mechanical dilator sheath equipped with rotating threaded tip.A 49 year old man (noncompaction cardiomyopathy, implantable cardioverter-defibrillator implantation) was referred for extraction of the malfunctioning right ventricular leads.An evolution mechanical dilator sheath (cook medical inc., bloomington, indiana) was used to dissect adhesions via superior approach.The whole systems were successfully extracted and new systems were implanted directly thereafter.The patient developed dyspnea and sleeping disorders gradually during the first 4 months of follow-up.Left hemidiaphragm paralysis was diagnosed.Due to severe dyspnea the patient underwent a successful surgical plication of diaphragm 1 year later.At follow-up visit after 2 years, the clinical symptoms improved; the right hemidiaphragm showed normal function while the left side displayed no movement on check x-ray.This paralysis is suggested to be related to the damage of the left phrenic nerve during the process of dissecting adhesions in those parts of the left subclavian vein that run in the close vicinity of the nerve.' from the a department of clinical electrophysiology, erasmus medical center, university medical center, rotterdam, the netherlands; b department of heart failure/heart transplantation, erasmus medical center, university medical center, rotterdam, the netherlands; and the c department of cardiothoracic surgery, erasmus medical center, university medical center, rotterdam, the netherlands.The authors have reported that they have no relationships relevant to the contents of this paper to disclose.All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors¿ institutions and food and drug administration guidelines, including patient consent where appropriate.For more information, visit the jacc: clinical electrophysiology author instructions page.Manuscript received december 19, 2016; revised manuscript received january 24, 2017, accepted february 2, 2017.J a c c : c l i n i c a l e l e ct rophy s i o l o g y v o l.3 , no.1 0 , 2 0 1 7 ª 2 0 1 7 the authors.P u b li s hed b y e l s e vi e r on behal f of the am e r i c an c o l l e g e of cardi o l o g y foundat ion.Thi s i s an op en ac c e s s art i c l e unde r t he cc by -nc-nd l i c ens e ( h t t p : / / c r e a t i v e commo n s.O r g / l i c e n s e s / b y - n c - n d / 4.0/ ).I s sn 2 4 0 5 - 50 0 x.

• Brand Name: LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
• Type of Device: VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7966950
• MDR Text Key: 123800641
• Report Number: 2522007-2018-00024
• 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: 06/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LR-EVN-11.0-RL
• Device Lot Number: UNKNOWN
• 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 Age: 49 YR