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

Catalog Number UNKNOWN

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Perforation (2001); Abdominal Cramps (2543); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.Pma/510(k) k172557.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2011.It is alleged that the [pt] 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, unavailable, or unchanged.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Appropriate term/code not available (3191) was selected for the alleged device tilt.Investigation: the following allegations have been investigated: vena cava/organ perforation, tilt, chest pain, shortness of breath, abdominal cramps.Investigation is reopened due to additional information provided.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.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 chest pain, shortness of breath, abdominal cramps are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Rpn and lot# are unknown.The alleged tulip is manufactured and inspected according to a41935 (tulip mi), a41936 (tulip qci).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 paraplegic, surgery.Patient is alleging tilt, vena cava/organ perforation.The patient further alleges chest pain, shortness of breath, and abdominal cramps.(b)(6) 2019, per a report from computed tomography (ct); ¿there is an inferior vena cava filter in place which demonstrates no evidence of abnormal tilt.The tip of the inferior vena cava filter is located inferior to the left renal vein and at or just below the margin of the right renal vein.No evidence of a fractured strut is seen.No evidence of inferior vena cava stenosis is seen.There is a questionable clear fat plane between the inferior vena cava and the distal end of the right anterior and posterior struts without evidence of involvement of an adjacent loop of bowel or psoas musculature.Impression: 1.There is questionable perforation of the distal end of the right anterior and posterior struts of the inferior vena cava filter into the adjacent fat.¿ (b)(6) 2019, per a report from computed tomography (ct) 2; ¿ivc filter with: mesenteric and vertebral body 4 mm perforation.Tilting with the apex against the ivc wall.No fracture, stenosis or migration.¿.

• 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: 9762554
• MDR Text Key: 182968212
• Report Number: 3002808486-2020-00256
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 77