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

Catalog Number UNKNOWN

Device Problem Structural Problem (2506)

Patient Problems Great Vessel Perforation (2152); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Investigation is still in progress.

Event Description

According to the initial reporter: this patient had a suprarenal günther tulip ivc placed approximately 5 years prior to obtaining this ct.Images showed the filter hook outside the lumen of the ivc and within hepatic parenchemya and possibly into the portal vein.Given that the patient was asymptomatic and that filter removal could lead to significant complications it was elected not to pursue retrieval.Patient outcome: according to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).Article: "procedural complications of inferior vena cava filter retrieval, an illustrated review" by keith b.Quencer et al, published 27apr2020.Summary of investigational findings: this complaint is based on the information provided from the journal article figure 8.This patient had a suprarenal günther tulip ivc placed approximately 5 years prior to obtaining ct.Images showed the filter hook outside the lumen of the ivc and within hepatic parenchemya and possibly into the portal vein.Given that the patient was asymptomatic, and that filter removal could lead to signfiicant complications it was elected not to pursue retrieval.Based on the imaging in the article an imaging review was provided.Per imaging reviewer´s findings: ¿figure 8 contains two axial and one sagittal reformatted image from a contrastenhanced ct scan of the abdomen and pelvis evaluating a suprarenal gunther tulip ivc filter after a dwell time of approximately 5 years.This demonstrates what appears to be perforation of the ivc filter wall at the 12:00 location by the ivc filter hook which appears to at least abut if not extend into the main portal vein.There are no significant signs of inflammation in this region and given the location of the ivc filter hook, a retrieval was not attempted.¿ per imaging reviewer´s impressions: ¿the article includes a number of filter brands, but this review is concentrated on the four examples of cook ivc filter related issues.Specifically figure 2, figure 6, and failure 8 are related to filter tilt and either perforation of the filter hook and/or embedment of the filter hook leading to utilization of advanced techniques to retrieve the filter and associated complication of vascular wall injury involving either the ivc wall and/or the adjacent artery as detailed above.The final cases of perforation seen in fig 8 was too extensive to recommend retrieval attempt.Each of the submitted cook cases in this review article demonstrate situations where advanced techniques would or have been required to successfully retrieve the ivc filter and the associated complications from these retrievals.The cause of the filter¿s configuration requiring advanced techniques was not the concentration of this article, nor discussed in this article.This latter information is important in determining if the filter performed appropriately, or if this configuration was a result of human or device error, and unfortunately cannot retrospectively be addressed from the date included in this review.¿ cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.According to the instruction for use potential adverse events that may occur include, but are not limited to, the following: vena cava perforation.No evidence to suggest that the device is not manufactured according to specification.Based on the provided information an exact cause for this event cannot be established.However, vena cava perforation is a known adverse event.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.Cook medical will continue to monitor for similar events.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: 12156400
• MDR Text Key: 261219340
• Report Number: 3002808486-2021-01569
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1