MAUDE Adverse Event Report: COOK INC 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 of Vessels (2135); Disability (2371); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter is non-healthcare professional.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is alleged that the plaintiff received a gunther filter on (b)(6) 2009.It is alleged that the plaintiff was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

It was reported the patient allegedly received an implant on (b)(6) 2009 via the right internal jugular vein due to a pelvic hematoma.The patient is alleging tilt and vena cava perforation.The patient further alleges chest pain and limited physical activity.Per the 31aug2018, computed tomography-abdomen and pelvis without intravenous nor oral contrast: "positive for caval perforation: a total of 4 prongs have perforate inferior vena cava series 2 image 49.Maximum distance prongs perforated 3.31mm series 2 image 9.Coronal images 5.76 degree tilt left to right series 3 image 38.Sagittal images 3.83 degree tilt posterior to anterior series 4 image 58.Per the 31aug2018, computed tomography-abdomen and pelvis without contrast: "findings: inferior vena cava filter: inferior vena cava filter is noted.The superior tip of the filter is noted approximately 2 cm below the level of the renal veins.The superior aspect of the filter is slightly tilted to the right compared to the inferior aspect.The 4 main limbs of the filter are seen protruding through the walls of the inferior vena cava with the limb on the left abutting the calcified aorta.No surrounding stranding or fluid collections are seen.No definite broken limbs are seen.The most posterior limb abuts the adjacent vertebra.".

Manufacturer Narrative

Additional information: h6-patient codes: vessels, perforation of (2135)-listed in ifu; chest pain (1776)- not listed in ifu; disability (2371)- not listed in ifu.H6-device codes: appropriate term/code not available (3191): perforation-listed in ifu; appropriate term/code not available (3191): tilt-not listed in ifu; appropriate term/code not available (3191): abuts-not listed in ifu.Method codes.Result codes.Conclusion codes.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.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.

Manufacturer Narrative

Additional information: investigation ¿ investigation reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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).Unknown if the reported chest pain and disability are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.The following allegations have been investigated: tilt.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.Product is manufactured, inspected and packaged by william cook europe a/s.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

No additional information provided at this time.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8304185
• MDR Text Key: 134968428
• Report Number: 1820334-2019-00311
• 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,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• 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: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 100