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

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Fatigue (1849); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Type  Injury  

Event Description

It is alleged that the patient received a celect inferior vena cava (ivc) filter on 2011, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 celect 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.

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: organ/vena cava perforation, embedded, tilt, bleeding, dyspnea, pain, physical limitations, and fatigue.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.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 bleeding, dyspnea, pain, physical limitations, and fatigue is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.The alleged celect 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 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.

Event Description

Patient allegedly received a filter (b)(6) 2011 due to a car accident.Patient is alleging device tilt, vena cava and organ perforation.Patient notes and further alleges experiencing pain, bleeding, tired, short of breath, cannot lay down or sit for too long as well as physical limitations.Per a computed tomography (ct) abdomen: "there is an inferior vena cava filter which is in appropriate location the superior tip of the ivc filter is located just below the insertion site of the left renal vein and does appear to contact the left lateral wall of the ivc.The angle of the filter lies 10 degrees relative to the longitudinal course of the ivc.In addition, there is perforation of number of the filter struts.The struts will be described in a clock position relative to the axial plane.At the 11 o'clock position, there is an extruded strut that extends 12 mm beyond the wall of the ivc and appears intimately associated with the duodenum and at least indents the posterior margin of the duodenum.The evaluation for possible perforation is difficult to ascertain.There is no adjacent stranding.At the 10 o'clock position, there is another perforated strut.This extends 6 mm beyond the wall of the ivc, interposed between a small probable vein and the posterior wall of the duodenum.At the 8 o'clock position, another strut extends also into the retroperitoneal fat extending 5 mm beyond the wall of the ivc.At the 7 o'clock position, there is a perforated strut which extends 12 mm beyond the wall of the ivc, the tip projecting within the anterior margin of the right psoas musculature.There are several additional struts extending from the 3 to 6 o'clock position that appear to extend through the ivc wall but are intimately associated with the wall of the ivc.There is no clear fat plane between the ivc wall and the struts.There is no abnormal retroperitoneal stranding or fluid collection.There is no ectopic gas"."impression: 1.Ivc filter in position as described.The filter tip appears embedded within the left lateral wall of the ivc just below the insertion site of the left renal vein".

• 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: 13293084
• MDR Text Key: 289173030
• Report Number: 3002808486-2022-00037
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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: 02/14/2022
• 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: 100 KG