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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/03/2023

Event Type  Injury  

Event Description

Description of event according to initial reporter: upon review of imaging, some components appeared to be extra caval, successful retrieval was performed and upon review, a secondary strut was missing and confirmed to be fractured, possibly embedded and extra caval.Upon attempting to retrieval fractured strut, no movement was noted when snare was spinning to capture said strut.Multiple orthogonal views were taken to demonstrate.Additional information received 29nov2023: we were unsuccessful in the attempt to retrieve the fractured secondary strut.The patient was asymptomatic.

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.D4) catalog# is unknown but referred to as cook celect filter g4) pma/510(k) k211875.Investigation is still in progress.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.

Manufacturer Narrative

Manufacturers ref# (b)(4).William cook europe has been unable to submit reports due to issues with receiving new ssl certificates for esg as2 trading partners from the esg help desk.This issue was discovered over the weekend of 25nov2023.Cook has been in communication with the fda regarding this issue and was provided the needed security certificate on 04dec2023.Per (b)(4), questions and answers about emdr - electronic medical device reporting - guidance for industry, user facilities and fda staff, section d: ""¿ if a manufacturer or importer is unable to submit a report on time due to an outage affecting the esg or the cdrh emdr processing system, it may document its attempts at timely filing in block h10 for the affected reports and submit reports electronically as soon as the esg or cdrh emdr processing system is operational."" an email has been sent to fda as the guidance instructs informing fda of the information set forth in the guidance regarding these delayed submissions.This report is required by the fda under 21cfr 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.

Manufacturer Narrative

Manufacturer ref# (b)(6) summary of investigational findings: upon retrieving a celect filter with unknown dwell time, some filter legs appeared to be extra caval.The filter was retrieved, but a secondary leg had fractured, possibly embedded/extra caval.Unsuccessful retrieval attempt of fractured leg, but the patient was asymptomatic.The celect pt filter was returned and a secondary leg had fractured as reported.However, a detailed sem analysis did not reveal any visible defects in the material, but showed that bending and rotational force were the main forces that led to the fracture and that fatigue and accumulation of loads led to the final fracture.Ct scan dated a month before retrieval and fluoroscopic images from the retrieval were provided.Also, a single fluoroscopic image was provided, but in a poor quality not confirming if a celect or a celect pt filter.Ct scan of the abdomen and pelvis with iv contrast demonstrates the celect pt ivc filter with the hook at the juxtarenal location.There are grade 3 interaction's involving each of these primary filter legs.There are no significant signs of stranding or haziness surrounding any of these primary filter legs.Seven of the secondary legs are still attached to the ivc filter.Several of these demonstrate grade 1 interactions with the wall of the ivc indicating tenting.Again, there are no significant signs of stranding or haziness present.The eighth secondary filter leg appears fractured with the fracture fragment apparently embedded in the anterior wall of the ivc, oriented perpendicular to the ivc.There is no clear intraluminal extension of this fracture fragment.Multiple fluoroscopic images from time of ivc filter retrieval demonstrate a celect pt ivc filter just to the right of the spine with approximately 9 degrees of rightward tilt present.All 4 primary legs are appreciated and have normal orientation.Seven of the secondary legs are also appreciated and have a normal orientation.The eighth secondary leg is seen oriented near perpendicular to the long axis of the ivc filter and appears separate from the neck of the ivc filter.Subsequent images demonstrate a gunther tulip retrieval set and a loop snare engaging with the hook of the ivc filter with successful retrieval of the ivc filter.With the filter removed the fracture segment of the secondary filter arm is more clearly identified.A clover snare device was used in attempts to capture the fractured fragment, without success.A followup inferior venacavogram demonstrates the filter projecting outside the left lateral margin of contrast opacifying the ivc, confirming at least a component of this fractured fragment is extravascular.A lateral projection was also included in which the fragment is not visualized.The dwell time was not discussed.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: vascular trauma, vena cava perforation, vena cava penetration.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.There are adequate controls in place to ensure that this type of device is manufactured to specifications.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.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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18264688
• MDR Text Key: 329672685
• Report Number: 3002808486-2023-00283
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 01/09/2024; 02/16/2024
• Supplement Dates FDA Received: 01/09/2024; 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female