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

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Renal Failure (2041); Transient Ischemic Attack (2109); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook ivc filter.(b)(4).Occupation: non-healthcare professional.Investigation is still in progress.

Event Description

'it is alleged that "[pt] received a cook filter in (b)(6) 2011".Reason for treatment: blood clots.It is also alleged: "perforation strut", "kidney failure", "pain", "difficulty using right leg due to swelling and numbness" and "transient ischemic attack (tia) " alleged: "still have ivc filter in right leg", "perforation strut", "kidney failure", "pain", "difficulty using right leg due to swelling and numbness" and "tia".

Event Description

Patient allegedly received an implant on (b)(6) 2011 via the right common femoral vein due to blood clots.Patient is alleging strut perforation.The patient further alleges ¿kidney failure, pain, difficulty using right leg due to swelling and numbness as well as tia.¿ per a ct (computed tomography) scan of the abdomen (b)(6) 2018, ¿there is an ivc filter in place.All 3 of the legs extending 2 to 3 mm beyond the expected lumen of the inferior ivc.The legs of the stent is not obviously contact the aorta, but may contact the third portion of the duodenum.¿.

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged vessel perforation.Investigation - vena cava wall penetration/perforation has been reported and 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.Unknown if the reported pain, difficulty using right leg due to swelling & numbness & tia are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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 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 ; DA 4632
• MDR Report Key: 8844798
• MDR Text Key: 152752734
• Report Number: 3002808486-2019-01094
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• 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: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR
• Patient Weight: 67