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

Catalog Number UNKNOWN

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Swelling (2091); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4) catalog# is unknown but referred to as cook celect filter occupation: non-healthcare professional.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

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2012.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Manufacturer Narrative

Additional information: investigation investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture, vena cava (vc)/organ/iliac artery/aorta/vertebral/psoas muscle/ perforation, migration, fear, anxiety, physical limitations, swelling, pain, lack of energy, cramps.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.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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.Unknown if the reported fear, anxiety, physical limitations, swelling, pain, lack of energy, and cramps are 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.The product is manufactured and inspected according to specifications.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.The following fields were updated per additional information received: a2, a4, b1, b5, b6, b7, h6.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become available.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

Patient allegedly received an implant on (b)(6) 2012 due to pulmonary embolism.Patient is alleging vena cava perforation, fracture, organ perforation.Patient further alleges fear, anxiety, aorta perforation, vertebral perforation, psoas muscle perforation, unable to stand for long periods of time, swelling in lower legs, pain in chest, lack of energy, cramps in lower abdomen, unable to walk for long distances.Report from computerized tomography (ct): "ivc filter with: migration.Left common iliac artery perforation -no tilting, stenosis, fracture.Cook celect filter." report from ct: "findings: metallic inferior vena cava filter is in place within the ivc and the proximal tip lies 4.9 cm below the right renal vein and 5.8 cm below the left renal vein.The proximal tip lies centrally within the ivc lumen.Broken filter strut is present at 2:00 and the fragment is displaced superiorly and lies transversely across the lumen of the ivc and perforates the left lateral ivc wall and lies posterior to the aortic bifurcation.Four additional struts also perforate the ivc wall including a strut at 3:00, and that strut penetrates into the lumen of the proximal left common iliac artery.Perforated strut at 12:00 lies just lateral to the right of the right common iliac artery, and additional strut at 6:00 penetrates posteriorly into the l4 vertebral body.Additional strut perforation at 9:00 just abuts the right psoas muscle.No significant stenosis of the ivc is evident either above or below the filter or at the filter level." "1.Caudal malposition of ivc filter with fracture of one filter strut which lies in transverse orientation across the lumen of the ivc and penetrates the left lateral wall.".

• 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: 10702934
• MDR Text Key: 212128087
• Report Number: 3002808486-2020-00974
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 120