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

Catalog Number UNKNOWN

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Name and address for importer site: (b)(4).Since catalog# is unknown 510(k) could be either k061815 or k073374.(b)(4).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 celect filter on (b)(6) 2008".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

Exemption number e2016032e lot.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

This additional information received on 06feb2018 as follows: pt allegedly received an implant on (b)(6) 2008 via the right common femoral vein due to history of deep vein thrombosis/pulmonary embolism.Pt is alleging device is unable to be retrieved.Additionally pt.Is alleging that due to a thrombosed ivc filter, stents were placed within the inferior vena cava.Pt.States was informed by md that following this procedure that the ivc filter could not be removed.

Manufacturer Narrative

Exemption number e2016032.(b)(4).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 'celect, thrombosed ivc filter (occlusion), unable to retrieve'.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.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.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 ; sandet 6; bjaeverskov 4632 4632 ; DA 4632 ; 56868686
• MDR Report Key: 7141449
• MDR Text Key: 95587147
• Report Number: 3002808486-2017-02508
• 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: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/06/2017
• Date Manufacturer Received: 03/16/2018
• 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; Required Intervention
• Patient Weight: 82