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

Catalog Number UNKNOWN

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.(b)(4).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

'it is alleged that "[pt] received a cook celect filter on (b)(6) 2009".It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged vena cava perforation.Investigation ¿ the following allegations have been investigated: vena cava perforation, fracture, embedded, pain, numbness.The reported allegations have been further investigated based on the information provided to date.Vena cava wall penetration/perforation has been reported and 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.A filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.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.Unknown if the reported pain and numbness 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, there is 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.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 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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.

Event Description

Patient allegedly received an implant on (b)(6) 2009 via unknown access to deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging vena cava perforation, fracture, retained tine/strut, embedded tine/strut.The patient further alleges ¿back pain and right side pain due to filter tine embedded within l3 vertebral body, bilateral leg pain alternating with leg numbness.When i learned about the filter perforation and embedment, i became extremely scared of further device failure causing life threatening injuries.I was anxious and depressed.I sought treatment through (name removed).¿ per a magnetic resonance imaging (mri) scan of the lumbar spine dated (b)(6) 2013, ¿a 9 x 18 mm t2 bright cystic focus is present in the right anterior aspect of the l3 vertebral body favoring a small interosseous cyst.The superficial margin of the cyst appears to bulge beyond the confines of the cortex.The overall configuration is not significantly changed from the subtle cystic focus present on the radio graphs.This may be related to reactive changes to one of the inferior vena cava filter struts adjacent to the vertebral body.¿ per a computerized tomography (ct) scan of the abdomen dated (b)(6) 2013, ¿a infrarenal inferior vena cava filter is demonstrated.Some of the struts project beyond the confines of the ivc lumen.One of the posterior struts abuts the right anterior aspect of the l3 vertebral body, with development of an 11 mm thin¿walled cystic focus.The wall of the cyst appears to partially grown around the strut.The medial strut of the ivc filter is in close proximity to the infrarenal aorta without complication.¿ per a computerized tomography (ct) scan of the abdomen dated (b)(6) 2017, ¿inferior vena cava filter in place.One strut is in close proximity to the infrarenal abdominal aorta without complication.There also appears to be a broken strut posteriorly which is associated with a cystic focus in the l3 vertebral body.¿ per inferior vena cava filter retrieval report performed (b)(6) 2018, ¿impression: status post successful retrieval of inferior vena cava filter with single retained extravascular tine embedded within the l3 vertebral body.Postremoval cavogram without evidence of caval injury or extravasation.¿ per lumbar spine x-ray dated (b)(6) 2018, ¿removal of previously noted inferior vena cava filter with probable residual broken limb.¿ per a computerized tomography (ct) scan of the lumbar spine dated (b)(6) 2018, ¿retained metallic wire in the right anterior aspect of l3 producing bony reactive change around it.This correlates the given clinical history.At this time no other retained foreign bodies are seen and no ivc filter is identified within the cava.¿ per lumbar spine x-ray dated (b)(6) 2018, ¿single extravascular tine from prior ivc filter again noted abutting the l3 vertebral body,¿.

• 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: 8648621
• MDR Text Key: 146331324
• Report Number: 3002808486-2019-00662
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• 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: 05/09/2019
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 106