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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a gunther tulip filter.(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 after further information is received and will supplement in accordance with 21 c.F.R.803.56 when appropriate.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a gunther tulip ((b)(4)) and a cook celect ((b)(4)) 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 received on 05/16/2017 as follows: plaintiff allegedly received an implant on or about (b)(6) 2015 due to continued chronic dvt and pe and to replace ivc filter removed on or about (b)(6) 2015.Plaintiff is alleging chronic pe and dvt despite filter.

Manufacturer Narrative

Exemption number e2016032.(b)(4).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 "chronic pulmonary embolism and dvt despite filter".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.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: 6212085
• MDR Text Key: 63475945
• Report Number: 3002808486-2016-01556
• 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: 08/02/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/06/2016
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided; 07/07/2017
• Supplement Dates FDA Received: 05/26/2017; 08/02/2017
• 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 Weight: 102