MAUDE Adverse Event Report: WILLIAM COOK EUROPE NAVALIGN COOK CELECT FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-8.5-1-FEM-CELECT

Device Problems Obstruction of Flow (2423); Structural Problem (2506); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Internal Organ Perforation (1987); Thrombus (2101); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref#: (b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2018.It is alleged that the [pt] was injured without further explanation.".

Event Description

Patient allegedly received an implant due to venous thrombosis (vt)/pulmonary embolism (pe).Patient is alleging organ perforation.Patient notes and further alleges experiencing "shortness of breath, chest pain, numbness in extremities and pain through out body." per the (b)(6) 2018 computed tomography (ct) abdomen pelvis with contrast: "impression: 1.Nonocclusive thrombus extending superiorly from the tip of the ivc filter to the ostium of the left renal vein.2.Nonocclusive thrombus through the right common and external iliac veins".

Manufacturer Narrative

Investigation: the following allegations have been investigated: organ perforation, thrombus, dyspnea, body/chest pain, extremity numbness.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported dyspnea, body/chest pain, extremity numbness are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: NAVALIGN COOK CELECT FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10618328
• MDR Text Key: 209554275
• Report Number: 3002808486-2020-00892
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K112119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2016
• Device Catalogue Number: IGTCFS-65-8.5-1-FEM-CELECT
• Device Lot Number: E3462999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening