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

Catalog Number UNKNOWN

Device Problem Device Tipped Over (2589)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994)

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 günter tulip filter placed 4 months prior to removal.The sling technique was employed given significant filter tilt.After removal, the patient developed abdominal pain and hypotension.Venogram showed extravasation of contrast and a flow limiting dissection.Balloon tamponade was performed but failed to resolve extravasation.Two overlapping 25mm cook-z stents (cook) were placed with improvement of flow and resolution of extravasation.Partial caval thrombosis secondary to stasis from balloon tamponade developed and a new ivc filter was placed above this clot.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: this complaint is based on the information provided from the journal article: procedural complications of inferior vena cava filter retrieval, an illustrated review" by keith b.Quencer et al, published 27apr2020, figure 6.It concerns a tulip filter which was observed to be tilted.After removal the patient developed pain and hypotension.A venogram showed extravasation of contrast and a flow limiting dissection.It was resolved with balloon tamponade and two stents.A new filter was placed afterwards due to partial thrombus development.Based on the imaging in the article an imaging review was provided.Per imaging reviewer´s findings: ¿figure 6 contains six fluoroscopic images from time of ivc filter retrieval.Per the caption, a gunther tulip ivc filter was placed 4 months prior to retrieval.The initial venogram faintly opacifies the ivc lumen and the gunther tulip ivc filter appears to have approximately 10 degree leftward tilt placing the hook of the ivc filter adjacent to the ivc filter wall.A glidewire sling technique was used to retrieve the ivc filter, presumably because the filter hook could not be captured with a loop snare in this configuration.The filter was removed with the sling technique, however, patient developed abdominal pain and hypotension following retrieval.A follow-up venogram demonstrates a very irregular appearance to the ivc filter lumen and wall consistent with areas of active extravasation.This was treated with balloon tamponade, however, the extravasation did not resolve.2 overlapping 25 mm cook-z stents were deployed across the area of irregularity demonstrating improved flow and resolution of extravasation.However, there was interval development of partial thrombosis of the infrarenal ivc as is seen on follow up venogram demonstrating intraluminal filling defect located below the level of the stents.This was treated with placement of a new ivc filter above the level of thrombus and below the level of the stents.¿ 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 cause of the filter tilt was not addressed nor evaluated in this article.Cases described in fig 6 and 2 were retrieved but demonstrated subsequent injury of the caval wall requiring stenting and injury to the right renal artery requiring embolization, respectively.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: unacceptable filter tilt there are adequate controls in place to ensure that this type of filter is manufactured to specifications.Based on the provided information it is unknown what caused the filter to tilt and difficult to retrieve.However, filter tilt is a known adverse event.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.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.

Event Description

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

• 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: 12148981
• MDR Text Key: 260931449
• Report Number: 3002808486-2021-01557
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• 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: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention