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

Catalog Number IGTCFS-65-JUG-CELECT-PERM

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)

Event Date 09/06/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog number: unknown but referred to as a cook celect filter.Since catalog number is unknown the 510(k) could be either k061815 or k073374.(b)(4).Investigation is still in progress.

Event Description

Description 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

Manufacturer ref# (b)(4).Catalog#: igtcfs-65-jug-celect-perm.According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this 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 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

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

Event Description

This additional information was received on 12/29/2016 as follows: the plaintiff allegedly received device implant via right jugular vein on (b)(6) 2008 due to dvt and underlying hypercoagulable state.The plaintiff alleges vena cava perforation, organ perforation, and erosion of vertebral body after implant of device.

Manufacturer Narrative

Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer reference # (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 "vena cava perforation, organ perforation, erosion of vertebral body".Cook will reopen its investigation if further information is received.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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: COOK CELECT JUGULAR VENA CAVA FILTER SET
• 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: 6224395
• MDR Text Key: 63912109
• Report Number: 3002808486-2016-01615
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• 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,Followup
• Report Date: 08/13/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/28/2016
• Device Age: 49 MO
• Initial Date Manufacturer Received: 12/27/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/21/2017
• Supplement Dates FDA Received: 02/21/2017; 04/28/2017; 08/13/2017
• Date Device Manufactured: 08/01/2007
• 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: 51 YR
• Patient Weight: 100