MAUDE Adverse Event Report: COOK VANDERGRIFT INC LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET

Catalog Number LR-PPLBES-10.0-XL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemothorax (1896)

Event Type  Injury  

Manufacturer Narrative

Date of death: exact date of patient death is unknown as the literature provided only indicates that the study occurred between october 2011 and december 2018.Common name: dilator, catheter.Product code: dws.(b)(6).Pma/510(k): 893480.(b)(4).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 investigation.

Event Description

As reported in literature finding, the following adverse event occurred during a case study for lead extraction procedures which took place between october 2011 and december 2018."hemorrhage to the pleural cavity requiring drainage occurred during extraction of 7.1-year-old dysfunctional sc icd (single coil implantable cardioverter) lead in a (b)(6) year-old patient with a dual-chamber icd (implantable cardioverter) and with a history of surgical correction of tetralogy of fallot.Ipsilateral venography showed subclavian vein patency and the presence of a loop created by icd (implantable cardioverter) lead inside subclavian vein.During the extraction of icd (implantable cardioverter) lead with green dilator sheath (cook lead extraction byrd polypropylene extra long dilator sheath set, lr-pplbes-10.0-xl) the left subclavian vein and left pleura were damaged." the adverse event sited in this excerpt is indicated to be damage to the left subclavian vein and left pleura, which required surgical intervention.No other consequences to the patient have been reported as occurring.At this time, no additional information is available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: h6- ec method code desc - 1: device not returned (4114).H6- ec results code desc - 1: no findings available (3221).H6- ec conclusions code desc - 1: known inherent risk of device (22).H10- added summary of investigation.Investigation-evaluation: as per journal article: effectiveness and safety of transvenous extraction of single- versus dual-coil implantable cardioverter-defibrillator leads at single-center experience: the aim of the study was to assess the effectiveness and safety of single- and dual-coil icd leads transvenous extraction using mechanical systems.We performed transvenous lead extraction (tle) of 197 icd leads in 196 patients.There were 46 (23.3%) dual-coil leads removed from 46 (23.5%) patients.Adhesions developing around the svc coil add to the difficulty of extraction of icd lead if lead removal is required.The selected groups of patients (scl and dcl) were compared by assessing demographic data (age, sex), body mass index (bmi), the new york heart association (nyha) functional classification and left ventricular ejection fraction (lvef), indications for icd implantation (primary or secondary prevention), comorbidities including diabetes mellitus and coronary artery disease, laboratory studies (hemoglobin concentration, creatinine level, estimated glomerular filtration rate [egfr]), types of implanted cied, number of cied-related procedures before tle (implantation, reimplantation, device upgrade), indications for tle.For each electrode removed, the efficiency according to the ehra consensus was determined: complete lead removal--lead explant or extraction with removal of all targeted lead material, incomplete lead removal--lead explant or extraction where part of the lead remains in the patient¿s body (vascular or extravascular).All the procedures were performed in hybrid operating room with on-site cardiothoracic surgical standby, under general anesthesia or intravenous sedation.While extracting the lead we used a stepwise approach.Simple traction was the first extraction technique used in active fixation and relatively young leads.At the next step we utilized nonpowered extraction tools.Standard stylets were used to stiffen the leads.If the lumen of the lead allowed the insertion of the stylet to its tip, the locking stylets (liberator beacon tip locking stylet, cook medical or lead locking device, spectranetics) were used from december 2013.We utilized telescoping dilators (cook medical, bloomington, in).Powered extraction tools (cutting sheath system--evolution, cook medical) were usually applied when previously used nonpowered extraction tools failed.In case of leads which were completely in the cardiovascular system either before the procedure or as a result of lead fracture during the procedure, the femoral approach was utilized.Laser techniques and electrosurgical sheaths were not used.As stated in literature finding, hemorrhage to the pleural cavity requiring drainage occurred during extraction of 7.1-year-old dysfunctional sc icd lead in a 26-year-old patient with a dual-chamber icd and with a history of surgical correction of tetralogy of fallot.Ipsilateral venography showed subclavian vein patency and the presence of a loop created by icd lead inside subclavian vein.During the extraction of icd lead with green dilator sheath the left subclavian vein and left pleura were damaged.Per ifu ((b)(4) rev002): "weigh the relative risks and benefits of intravascular catheter/lead removal procedures in cases when: the item to be removed is of a dangerous shape or configuration, the likelihood of catheter/lead disintegration resulting in fragment embolism is high or vegetations are attached directly to the catheter/lead body.Catheter/lead removal devices should be used only at institutions with thoracic surgical capabilities." "catheter/lead removal devices should be used only by physicians knowledgeable in the techniques and devices for catheter/lead removal." "potential adverse events related to the procedure of intravascular extraction of catheters/leads include (listed in order of increasing potential effect): dislodging or damaging nontargeted catheter/lead, chest wall hematoma, thrombosis, arrhythmias, acute bacteremia, acute hypotension, pneumothorax, stroke, migrating fragment from catheter/object, pulmonary embolism, laceration or tearing of vascular structures or the myocardium, hemopericardium/pericardial effusion, cardiac tamponade, hemothorax, cardiac arrest, death." 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.- attachment: [zabek_single vs dual icd leads_journal article 2019.Pdf].

Event Description

As per complaint form: hemorrhage to pleural cavity.As stated in literature finding, "hemorrhage to the pleural cavity requiring drainage occurred during extraction of 7.1-year-old dysfunctional sc icd lead in a 26-year-old patient with a dual-chamber icd and with a history of surgical correction of tetralogy of fallot.Ipsilateral venography showed subclavian vein patency and the presence of a loop created by icd lead inside subclavian vein.During the extraction of icd lead with green dilator sheath the left subclavian vein and left pleura were damaged.".

• Brand Name: LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET
• Manufacturer (Section D): COOK VANDERGRIFT INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 9144885
• MDR Text Key: 163120557
• Report Number: 2522007-2019-00014
• Device Sequence Number: 1
• Product Code: GCC
• Combination Product (y/n): N
• PMA/PMN Number: K893480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LR-PPLBES-10.0-XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR