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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Nausea (1970); Internal Organ Perforation (1987); Swelling (2091); Great Vessel Perforation (2152)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Initial reporter occupation: non-healthcare professional.Pma/510(k) k172557.Summary of investigational findings: the reported allegations have been further 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.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.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: it is alleged that "on or about (b)(6) 2015, [pt] was implanted with a cook gunther tulip¿ vena cava filter.On or about (b)(6) 2018, [pt] underwent a computerized tomography scan (ct scan) of his abdomen.Subsequently, in addition to other failures, [pt] was informed that the ct scan revealed that the struts of the gunther tulip¿ vena cava filter had perforated outside of the wall of the ivc into adjacent organs, causing bodily injuries." patient outcome: it is alleged that "[pt] faces numerous health risks, including the risks of death.[pt] will require ongoing medical care and monitoring for the rest of his life.".

Manufacturer Narrative

The following fields were updated per additional information received: a2, a4, b5, b6, b7, and h6.Investigation: the following allegations have been investigated: tilt, legs/abdominal swelling, nausea.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported legs/abdominal swelling, and nausea 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, 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.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 06jul2015 via right common femoral vein due to hematoma of the spine.The patient alleges vena cava perforation and tilt.The patient further alleges legs/abdominal swelling and nausea.On (b)(6) 2018, per a report from computed tomography; ¿an ivc filter is present.The filter is approximately 6 mm below the renal veins.The filter lies in a 12 o¿clock position in relation to the ivc.The longer tines of the filter do protrude outside the lumen of the ivc within a symmetrical pattern.No definite vital structures are contacted though the left tine is near the wall of the aorta.No broken tines.No malalignment.¿ on (b)(6) 2018, per a report from computed tomography 2; ¿impression: infrarenal ivc cook gunther tulip filter with apex likely adherent to posterior caval wall and 4 leg filter perforation, 2 of which involve viscera, adjacent organs.Pericaval inflammatory change at level of ivc filter.¿.

• 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: 10506738
• MDR Text Key: 208106572
• Report Number: 3002808486-2020-00867
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 79