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

(b)(4).Catalog# is unknown but referred to as cook celect filter.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) 2016.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) 2016 via the right groin due to deep vein thrombosis and pulmonary embolism.The patient alleges organ and vena cava perforation.The patient further alleges chest pain, abdominal pain, shortness of breath, swellings in legs and feet, limited mobility as well as depression, fear, and anxiety.(b)(6) 2016, per a report from radiology; ¿ivc filter is infrarenal in position.The posteromedial filter is seen piercing the respective wall of ivc (10.10mm) and impinges the prevertebral structures.The anteromedial filter of ivc is seen piercing the respective wall of ivc (8.47mm) and is lying adjacent to the duodenum.The anterolateral filter is seen piercing the respective wall of ivc (10.24 mm) and impinges the duodenum.The posterolateral filter is seen piercing the respective wall of ivc (8.25mm).No tilt of the ivc filter is noted.No ivc filter fracture noted.¿.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: organ/vc perforation, chest/abdominal pain, shortness of breath, legs/feet swelling, limited mobility, depression, fear, and anxiety.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/abdominal pain, shortness of breath, legs/feet swelling, limited mobility, depression, fear, and anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown; however, the alleged celect 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 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: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10249640
• MDR Text Key: 198092334
• Report Number: 3002808486-2020-00696
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 91