MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.Pma/510(k) k172557.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 gunther tulip filter in (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 on (b)(6) 2013 due to pulmonary embolism (pe).Patient is alleging vena cava and organ perforation.Patient notes and further alleges experiencing sharp pinching pain in the chest while bending down to lift, stretching out the arms, and when riding a bike or hiking.Per the (b)(6) 208 computed tomography (ct) abdomen without contrast: "a filter is seen within the infrarenal inferior vena cava.The filter is perfectly aligned with the orientation of the inferior vena cava, with no evidence of tilt (0 degree).The apex of the filter is centrally located in the lumen of the ivc, and does not tightness the wall.The apex is positioned below the origin of the left renal vein, and 7 mm cephalad to the level of the right renal vein.The majority of the struts extend through the wall the inferior vena cava.Some structures appear to extend to the edge of the duodenum.No definite perforation is identified, although the possibility is difficult to completely exclude.One strut extends 18 mm beyond the ivc wall, into a lumbar vertebral body which likely represents l3, assuming that the lowest hypoplastic ribs arising from l 1.Prior to any surgical procedure, correlation of vertebral bodies with additional imaging studies is recommended.No fracture or bent strut is seen.No migrated filter fragment is seen.The inferior vena cava shows normal morphology throughout".

Manufacturer Narrative

Investigation: the following allegations have been investigated: organ/vena cava perforation, chest pain, physical limitations.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.Unknown if the reported chest pain, physical limitations is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.The alleged tulip is manufactured and inspected according to 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 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: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10873638
• MDR Text Key: 217306995
• Report Number: 3002808486-2020-01069
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 84