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

Catalog Number UNKNOWN

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)

Patient Problems Pain (1994); Thrombus (2101); Anxiety (2328); No Information (3190); No Code Available (3191)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog #: unknown but referred to as a cook gunther tulip filter.Expiration date: unknown as lot # is unknown.Since catalog # is unknown the 510(k) could be either k090140, k112119 or k121057.Mfr date unknown as lot # is unknown.Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "on (b)(6) 2015, [pt] had a gunther tulip filter installed into her inferior vena cava." on (b)(6) 2015, doctors attempted to remove the gunther tulip filter but were unable to do so; the physicians also found a clot in the filter post operation." 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).Catalog#: unknown but referred to as a cook gunther tulip filter.Since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057.(b)(4).It has not been possible to properly investigate or evaluate this alleged event based on the limited information provided in the lawsuit to date and reported herein.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description according to short form complaint filed: it is alleged that "on (b)(6) 2015, [pt] had a gunther tulip filter installed into her inferior vena cava." on (b)(6)2015, doctors attempted to remove the gunther tulip filter but were unable to do so; the physicians also found a clot in the filter post operation." 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 04/24/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the due to deep vein thrombosis and pulmonary embolism.Plaintiff is alleging device is unable to be retrieved, pain, anxiety, irregular heartbeat.Plaintiff alleges attempted retrieval on (b)(6) 2015.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(4).Additional information: 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 "tulip: thrombus, unable to retrieve, pain, anxiety, irregular heartbeat - updated sfc." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Ivc filter thrombus, or clot in ivc filter, is an outcome where the filter has either entrapped a clot that has embolized from an upstream source, such as a deep vein thrombus, or where a clot has formed on or within the filter.Filter thrombus can either resolve through the process of thrombolysis, remain stationary without subsequent sequelae, or alternatively provide a nidus for additional clot formation.The presence of a filter thrombus could preclude the removal of the filter during a retrieval process due to potential dislodgement of the thrombus which could cause a downstream occlusive event, e.G.Pulmonary embolism.Ivc filter thrombus is documented by ultrasound (us), ct, mr imaging or venography.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.Unknown if the reported pain, anxiety, irregular heartbeat are directly related to the filter.Catalog number and lot number are unknown, but the filter is manufactured and inspected according to specification.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.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.

Event Description

No additional information provided at this time.

Event Description

Additional information received identified that per the (b)(6) 2015, retrieval report 2 (unsuccessful): "conclusions: unsuccessful inferior vena cava filter removal.Inferior vena cava with thrombus in inferior vena cava filter.A 30.0x120 goose neck snare was used from the groin in association with the inferior vena cava retrieval kit from the rt to collapse previously implanted inferior vena cava filter for removal.The recapture was unsuccessful.A post angio of the inferior vena cava was performed and showed a clot in the inferior vena cava.The inferior vena cava was left in place".

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

• 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: 5931911
• MDR Text Key: 54022578
• Report Number: 3002808486-2016-01034
• 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,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• 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
• Distributor Facility Aware Date: 08/24/2016
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 41 YR
• Patient Weight: 53