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

Model Number G44155

Device Problem Insufficient Information (3190)

Patient Problems Thrombus (2101); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

Additional information received on (b)(6) 2017 as follows: [pt] allegedly received an implant on (b)(6) 2014 via the femoral vein due to illio-caval deep vein thrombosis.Pt is alleging bleeding, thrombus present below the vena cava filter, continuous blood clots in the legs.Device retrieval was performed on (b)(6) 2014 due to a large amount of thrombus below the vena cava filter, retrieval was successful.It is alleged that "[pt] received two gunther tulip filters; first filter on (b)(6) 2014 (b)(4) and second filter on (b)(6) 2014 (b)(4) at (b)(6) medical center, (b)(6).

Manufacturer Narrative

Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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 its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Catalog and lot# are unknown, but the tulip filter is manufactured and inspected according to specifications.

Event Description

No additional information provided at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable or unchanged.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, thrombus below ivc (occlusion), bleeding, blood clots in the legs'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.Unknown if the reported peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode at this 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.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK MEDICAL; 400 daniels way; bloomington IN 47404
• MDR Report Key: 7141168
• MDR Text Key: 96019469
• Report Number: 1820334-2017-04496
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002441552
• UDI-Public: (01)00827002441552(17)161101(10)4625238
• 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: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G44155
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 66