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 Perforation (2001); Thrombosis (2100); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Patient code and device code: no information regarding the event has been provided.Occupation: 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) 2008.It is alleged that the plaintiff was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Corrected data.Additional information: investigation.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating "tulip:-vc perforation, dvt -updated sfc." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Unknown if the reported dvt is directly related to the filter and unable to identify a corresponding failure mode at this point in time.The catalog # and lot # are unknown, but the filter tulip 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.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 has been provided at this time.

Event Description

Patient allegedly received an implant on (b)(6) 2008 via the right common femoral vein due to deep vein thrombosis and pulmonary embolism.Patient alleges perforation strut.Patient further alleges post-implant deep vein thrombosis.Per ct, (b)(6) 2018:"ivc filter with extraluminal positioning of the struts.

Manufacturer Narrative

F10: patient code: thrombosis (2100)- listed in ifu, perforation (2001)- listed in ifu device code:appropriate term/code not available (3191)-[device perforation]- listed in ifu.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

Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Catalog number and lot number are unknown, however, the alleged tulip 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

Per a report from computed tomography (ct): "findings: ivc stenosis: no, filter position: below the level of the renal veins, filter migration: none, filter fracture/bending: no, filter tilt: no, filter penetration: yes, other findings: no"."impressions: the anterior strut penetrates 2mm through the ivc wall.Coronal image 113.The anterior left strut penetrates 2mm through the ivc wall.Sagittal image 161.The posterior right strut penetrates 7mm through the ivc wall.Sagittal image 170.The posterior left strut penetrates 5mm through the ivc wall.Coronal image 119".

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8206284
• MDR Text Key: 131717077
• Report Number: 1820334-2018-03732
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/03/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 01/08/2019; 02/21/2019; 10/25/2023
• Supplement Dates FDA Received: 02/08/2019; 03/18/2019; 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Sex: Female
• Patient Weight: 127 KG