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

Catalog Number IGTCFS-65-1-FEM-TULIP

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Death (1802); Heart Failure (2206); No Information (3190)

Event Date 12/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #: unknown but referred to as a cook günther 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 "[pt] received a gunther tulip filter on (b)(6) 2015." 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 günther tulip filter since catalog# is unknown the 510(k) could be either k090140, k112119 or k121057.(b)(4).Information regarding the event has not been provided.It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received.If additional information is received, the report will be re-opened for further investigation.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2015".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).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 gunther tulip filter on (b)(6) 2015".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 11/18/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the right common femoral vein due to dvt with contraindication to anticoagulation.Plaintiff is alleging device fractured allowing a blood clot to travel to the heart causing a fatal heart attack on (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 'device fractured allowing a blood clot to travel to the heart causing a fatal heart attack'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Unknown if the reported patient death is related to the filter.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 a filter fragment embolized into the heart or lung may be safely retrieved.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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: investigation.Investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 includes information known at this time.A follow-up medwatch report will be submitted if 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.

Event Description

Death certificate: "immediate cause-(finial disease or condition resulting in death): cardiac arrest secondary to myocardial infraction.Sequentially 1st conditions, if any, leading to the cause listed on line a: urosepsis.Enter the underlying cause (disease or injury that initiated the events resulting in death) last breast cancer" "part ii: enter other significant conditions contributing to death but not resulting in the underlying cause given in part 1: deep vein thrombosis".

• Brand Name: GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6042812
• MDR Text Key: 57917757
• Report Number: 3002808486-2016-01267
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-FEM-TULIP
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/10/2016
• Device Age: 11 MO
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 81 YR