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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Dyspnea (1816); Internal Organ Perforation (1987); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged tulip 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.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.

Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2011, and the patient 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: organ/vena cava (vc) perforation, embedment, chest pain, dyspnea.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.Unknown if the reported chest pain and dyspnea are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The catalog # and lot # are unknown, but the filter 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.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.

Event Description

Patient allegedly received an implant on (b)(6) 2011 via the right common femoral vein due to status post pulmonary embolism (pe).Patient is alleging vena cava/organ perforation and embedment.Patient further alleges chest pain and shortness of breath.Report from ct (computed tomography): "filter tilt: there is no tilting of the tip of the filter.Position of the ivc filter: the ivc filter appears normally situated.The tip of the filter is 0.5cm below the visible right renal vein.Perforation the on the ivc wall: there is perforation of all 4 of the inferior struts, with 1.8 millimeter distance between the wall of the ivc and the margin of the striae in the 12 o'clock, 3 o'clock and 6 o'clock positions.There is 2.7 millimeter displacement of the lateral strut at 9 o'clock.The strut at 3 o'clock contacts the periphery of the aortic wall on axial image 40 series 2.No adjacent aortic wall or retro peritoneal hematoma identified.Other portions of the filter demonstrate tissue embedment evenly space between the struts at 12, 3, 6, and 9 o'clock.Filter strut fracture or bending: there is no strut fracture of bending visible.Stenosis of the inferior vena cava: there is no ivc stenosis.".

• 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
• MDR Report Key: 15870078
• MDR Text Key: 304364995
• Report Number: 3002808486-2022-01032
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• 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
• Date Manufacturer Received: 12/07/2022
• 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: Female
• Patient Weight: 91 KG