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

Catalog Number UNKNOWN

Device Problems Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907)

Patient Problems Occlusion (1984); Thrombosis (2100); Thrombus (2101); Great Vessel Perforation (2152)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.Summary of investigational findings: the reported allegations have been investigated based on the information provided to date.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.Rpn/lot# is unknown but there is no evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to short form complaint filed: "it is alleged that "[pt] received a cook celect filter on (b)(6) 2009.It is alleged that the [pt] was injured without further explanation." additional information provided 20may2020: patient allegedly received an implant on (b)(6) 2009 via the right common femoral vein.(b)(6) 2019, per a report from computed tomography (ct); ¿ivc filter at l3.At least 6 of the legs of the filter extend beyond the walls of the inferior vena cava into the retroperitoneal fat, without penetration of the abdominal aorta, lumbar spine, bowel, or kidneys".Patient outcome: it is alleged that the [pt] was injured without further explanation.

Event Description

Patient allegedly received an implant on (b)(6) 2009 due to bilateral pulmonary embolisms.The patient alleges vena cava perforation, fracture, both legs positive for continued dvt, and thrombus.The patient further alleges leg swelling, neuropathy in both feet, left leg limp, severe leg and feet pain, limited mobility, shortness of breath, pain in chest, fear, anxiety, emotional distress, suicide attempts, and loss of circulation.(b)(6) 2016, per a report from computed tomography; ¿ivc filter is unchanged in position.The posterior medial leg of the ivc filter appears to be fractured was located within the l3 vertebral body, unchanged from prior examination.Ivc below the filter is small likely chronically occluded as there are venous collaterals extending from the common femoral superiorly along the anterior abdominal and chest wall.¿.

Manufacturer Narrative

Code(s): swelling (2091), pain (1994), anxiety (2328).The following allegations have been investigated: fracture, deep vein thrombosis (dvt)/thrombus/occlusion, leg swell/pain, feet neuropathy/pain, left leg limp, limited mobility, shortness of breath (sob), chest pain, fear/anxiety/emotional distress, loss of circulation.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported leg swelling/pain, feet neuropathy/pain, left leg limp, limited mobility, shortness of breath (sob), chest pain, fear/anxiety/emotional distress, suicide attempts, and loss of circulation 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; 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 includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes 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.

• 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: 10131735
• MDR Text Key: 195778904
• Report Number: 3002808486-2020-00588
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• 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: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening