MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-JUG-TULIP

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

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a gunther tulip filter.Since catalog# is unknown the 510(k) could be either k090140 or k112119.(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) 2012".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).Outcomes attributed to device: device unable to be retrieved/difficult to remove (unsuccessful retrieval listed in ifu).The event is currently under investigation.A supplemental report will be provided upon completion.

Event Description

This additional information received on 2/14/2017 is as follows: implant date: (b)(6) 2012.Reason for implant: dvt and anticoagulation; gunther tulip cook; unknown lot number; placement physician: dr.(b)(6) hospital.Patient is alleging "device is unable to be retrieved; embedded".Failed retrieval attempt.

Manufacturer Narrative

(b)(4).Investigation is reopened due to additional information provided.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 "device is unable to be retrieved; embedded" cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Difficult filter retrieval due to embedment of filter legs or filter hook in the ivc wall is a well-known risk reported in the published scientific literature.Several case reports published in articles, describe successful endovascular retrievals of such filters by advanced retrieval techniques.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: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; 400 daniels way; bloomington, IN 47404 ; 8004574500
• MDR Report Key: 6208849
• MDR Text Key: 63412014
• Report Number: 3002808486-2016-01533
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/06/2016
• Date Manufacturer Received: 05/04/2017
• 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: 94