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

Catalog Number IGTCFS-65-1-FEM-CELECT

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturers 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) 2013.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Event Description

Patient allegedly received an implant due to trauma, implanted after a car accident.Patient is alleging vena cava perforation as well as 1 limb perforating the psoas muscle, 2 limbs perforated anteriorly, and 1 limb perforated the vertebra.The patient further alleges gasping for air causing physical limitations.Per a computerized tomography (ct) scan of the abdomen and pelvis dated on (b)(6) 2019, ¿no evidence of tilt.1 limb perforating the psoas muscle, 2 limbs perforated anteriorly and 1 limb perforated the vertebra.¿.

Manufacturer Narrative

The following fields were updated per additional information received.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava (vc)/organ perforation, gasping for air, physical limitations.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.Unknown if the reported gasping for air, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No other complaints on lots.Product is manufactured and inspected according to current controls.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 medwatch report will be submitted if additional relevant information becomes available.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.

• Brand Name: COOK CELECT NAVALIGN 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: 9749545
• MDR Text Key: 183138244
• Report Number: 3002808486-2020-00245
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2016
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E3126080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 91