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

Catalog Number UNKNOWN

Device Problem Structural Problem (2506)

Patient Problems Perforation of Vessels (2135); Anxiety (2328)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.Investigation: the following allegations have been investigated: vena cava perforation.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.Catalog number and lot number are unknown; however, the alleged tulip 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 medwatch report will be submitted if additional relevant information becomes available.

Event Description

The following information is alleged: the patient received two gunther tulip inferior vena cava (ivc) filters on (b)(6) 2012 due to deep vein thrombosis.Approximately seven years and three months later, it was discovered that both filters moved as several struts now perforated the ivc wall.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received two gunther tulip filter implants on (b)(6) 2012 via the right femoral vein due to deep vein thrombosis (dvt).Patient is alleging vena cava perforation.The patient further alleges anxiety.Implant report: "access was gained into the right femoral vein using an art needle." "we then deployed the gunther tulip ivc filter in the ivc below the insertion of the right renal vein and subsequent angiogram shows good apposition of the filter to the ivc." "the second gunther tulip filter was placed in a separate second ivc below the insertion of the left renal vein and subsequent imaging shows good apposition of the filter to the ivc." report from ct (computed tomography): "bilateral ivcs are noted.Bilateral ivc filters are noted.Right-sided ivc struts lie external to the right-sided ivc by 2 to 4 mm.Left-sided ivc struts extend beyond the lumen of the ivc by approximately 1 to 2 mm.".

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.Unknown if the reported anxiety 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.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 supple 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.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer Contact: lissi walmann ; sandet 6; bjaeverskov 4632 ; 56868686
• MDR Report Key: 12514438
• MDR Text Key: 272753208
• Report Number: 3002808486-2021-01807
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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: 10/20/2021
• 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: 129 KG