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

Catalog Number UNKNOWN

Device Problems Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook gunther tulip filter.(b)(4).Investigation is still in progress.

Event Description

"the physician has identified on mri what they think is a tulip filter that has penetrated the ivc and is lodged in the vertebral body.They have not attempted to retrieve it yet".Patient outcome: unknown.

Event Description

Additional information received 27mar2019: the device has been retrieved.The leg in the vertebral body did come out with the filter.A secondary strut that was also in the vertebral body did not come out, but it was outside the caval wall so i wasn¿t worried about it and couldn¿t get to it.¿.

Manufacturer Narrative

Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: (b)(4).Pma/510(k) k172557.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.

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).Summary of investigational findings: it was reported that the ivc filter was retrieved but a secondary strut was left in the patient, outside of the ivc and still embedded in the bone.However, the physician "wasn't worried about it and couldn't get to it".On the limited images submitted for review, there does appear to be a gunther tulip ivc filter in the infrarenal ivc.There is no evidence of significant tilt.There are two grade 3 interactions present and two grade 2 interactions present.The primary filter leg at the 9:00 region appears to abut either the right gonadal vein or potentially the right ureter without any significant changes to suggest inflammation or hemorrhage.The primary filter leg at the 6:00 region abuts the l3 vertebral body and has incited a prolific sclerotic bony reaction creating a bridging osteophyte extending between the l3-l4 vertebral body.As seen on the venogram images from time of ivc filter retrieval, and confirmed in the complaint report, the ivc filter was retrieved.However, the complaint report states a secondary strut was left in the patient, outside of the ivc and still embedded in the bone.This is not appreciated on the post-retrieval fluoroscopic image and may be a limitation due to the lower resolution of the image provided for review.The cause of filter fracture in this case is indeterminate.However, 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).Furthermore, retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques may include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.No product was returned and device name, rpn and work order number is unknown.No evidence to suggest this device was not manufactured to specifications.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: 8407044
• MDR Text Key: 138348747
• Report Number: 3002808486-2019-00284
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• 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
• Distributor Facility Aware Date: 02/19/2019
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening