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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Anxiety (2328); No Information (3190)

Event Date 06/07/2010

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog#: unknown but referred to as a cook günther tulip filter.(b)(4).Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2010".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

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

Event Description

This additional information was received on 04/06/2017 as follows: the patient allegedly received the device implant on (b)(6) 2010 due to pe with inability to anticoagulate following back surgery.An unsuccessful attempted removal allegedly occurred on (b)(6) 2010.The patient is alleging tilt, thrombus in filter, device is unable to be retrieved, and anxiety.

Manufacturer Narrative

Manufacturer ref # (b)(4).Exemption number e2016032.(b)(4).Corrected data based on new information received: adverse event to product problem, serious injury to malfunction.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 'tilt, thrombus in filter, device unable to be retrieved, anxiety'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.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 anxiety 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): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; 400 daniels way; bloomington, IN 47404 ; 8004574500
• MDR Report Key: 6412445
• MDR Text Key: 70171853
• Report Number: 3002808486-2017-00838
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/13/2017
• Date Manufacturer Received: 08/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR
• Patient Weight: 73