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

Catalog Number UNKNOWN

Device Problems Fracture (1260); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pulmonary Embolism (1498); No Information (3190)

Event Date 07/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a cook celect filter.Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140.(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 (b)(6) 2010 via the right jugular vein due to history of chronic pe and dvt.Plaintiff is alleging tilt, fracture, and chronic pe despite filter.Patient alleges successful retrieval on or about (b)(6) 2015, with subsequent implantation of another ivc filter on or about (b)(6) 2015.

Manufacturer Narrative

(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 "pulmonary embolism, fracture, and tilt".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.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), 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.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that filter fragment embolized into the heart or lung may be safely retrieved.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.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.

Manufacturer Narrative

Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: embedded.A filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).

Event Description

Dated 28jul2015, angio abdominal/pelvis ct reports, "extensive thrombosis of the ivc extending from inferior to the celect ivc filter to involve the included bilateral common, external iliac and common femoral veins." dated 30jul2015, ir venocavagram inferior reports, "successful bilateral lower extremity diagnostic venogram and cavagram demonstrating thrombosis of the ivc below the level of the filter.Dated 05aug2015, ir embolization (filter retrieval) reports, "subsequent cavogram was performed which demonstrated a patent suprarenal ivc but complete thrombosis at the level of the filter.A retrievable non-cook filter was then deployed in an appropriate position.Two remaining filter limbs were embedded in the ivc, and despite multiple attempts they were unable to be snared.Uneventful and technically successful placement of a non-cook suprarenal ivc filter with removal of an indwelling infrarenal filter." dated 07aug2015, bilateral extremity venogram (fragment retrieval) reports, "an embedded limb of the previous infrarenal filter was retrieved.A second additional limb appears to be outside of the ivc.".

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6212083
• MDR Text Key: 63475883
• Report Number: 3002808486-2016-01563
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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
• Distributor Facility Aware Date: 12/06/2016
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR
• Patient Weight: 102