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 Problems Perforation of Vessels (2135); Anxiety (2328); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture, vena cava (vc) perforation.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.Catalog and lot numbers are unknown, however, the alleged celect is manufactured and inspected according to controls 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.

Event Description

The following information is alleged: the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2013 and struts of the filter have perforated the ivc.One strut abuts the l3 vertebral body; one strut has fractured proximally, protruding outside of the ivc lumen and another strut is missing.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received a filter via the right femoral vein due to deep vein thrombosis (dvt) of left lower extremity with pulmonary embolism (pe), despite anticoagulants.Patient is alleging vena cava perforation which is abutting an organ and device fracture.Patient notes and further alleges experiencing one filter strut "is abutting my l3 vertebral body.Further, one strut has fractured proximally, protruding outside of the ivc lumen.I live with the anxiety of having a filter that could fail further at any time, but that cannot be retrieved without a serious surgery.I am worried because my filter has fractured and perforated outside my vena cava abutting another organ", physical limitations, bipolar disorder, agoraphobia, and paranoia.

Manufacturer Narrative

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: anxiety, worry, physical limitations, bipolar disorder, agoraphobia, paranoia.Unknown if the reported anxiety, worry, physical limitations, bipolar disorder, agoraphobia, and paranoia are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown, however, the alleged celect is manufactured and inspected according to controls.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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, dk-4632; bjaeverskov
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12616626
• MDR Text Key: 276423263
• Report Number: 3002808486-2021-01865
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening
• Patient Sex: Male
• Patient Weight: 111 KG