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

Catalog Number UNKNOWN

Device Problems Bent (1059); Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Emotional Changes (1831); Pain (1994); Perforation of Vessels (2135); Injury (2348); No Information (3190)

Event Date 01/26/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog number unknown but referred to as a cook gunther tulip filter.Investigation is still in progress.

Event Description

Description according to complainant: it is alleged that "on or about (b)(6) 2010, [pt] had a cook gunther tulip ivc filter implanted at an unnamed hospital in the state of (b)(6), pursuant to a doctor's order.On or around (b)(6) 2015 [pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable.Patient outcome: it is alleged that "[pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable.As a direct and proximate result of these injuries, [pt] has incurred and will incur medical expenses in the future, has endured and will endure pain and suffering and loss of enjoyment of life, and [pt] has otherwise been damaged in a personal and pecuniary nature.".

Manufacturer Narrative

(b)(4).Summary of investigational findings: patients medical records are unknown and no imaging is provided.Therefore, it is not possible to comment on the significant physical personal injuries directly and proximately caused by the ivc filter, which patient allegedly suffered approx.4½ years after placement of a tulip filter, because the filter became "imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable." also, it is not possible to comment on the medical expenses, which patient allegedly has incurred and will incur in the future, the pain and suffering and loss of enjoyment of life, the patient has endured and will endure, as well as the patient otherwise being damaged in a personal and pecuniary nature.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during filter placement or during filter implanting period.Under normal conditions, i.E.Ivc < 30 mm, the radial force of the filter will ensure proper attachment of the filter legs to ivc.However, filter migration is a known risk in relation to filter implant reported in the published scientific literature.Manipulation in the area of the filter implant or a blood clot captured inside the filter may cause migration or contribute to changes in the filter configuration and placement.Ifu, contraindications: megacava (diameter of the ivc > 30mm).Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.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.From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk.Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques.Rpn and lot# are unknown, but there is 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 medical will continue to monitor for similar events.

Event Description

Description according to complainant: it is alleged that "on or about (b)(6) 2010, [pt] had a cook gunther tulip ivc filter implanted pursuant to a doctor's order.On or around (b)(6) 2015 [pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable.Patient outcome: it is alleged that "[pt] suffered significant physical personal injuries directly and proximately caused by the aforementioned ivc filter becoming imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable.As a direct and proximate result of these injuries, [pt] has incurred and will incur medical expenses in the future, has endured and will endure pain and suffering and loss of enjoyment of life, and [pt] has otherwise been damaged in a personal and pecuniary nature.".

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 11/dec/2017 as follows: patient received an implant on (b)(6) 2010 via the right internal jugular vein due to deep vein thrombosis and upper gi bleeding.Patient is alleging pain, suffering, that the filter bent and fractured, and that the device is unable to be retrieved, retrieval was attempted on (b)(6) 2011.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(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 'tulip, tilt, vc perforation, bent, fracture, migrated, occluded, unable to retrieve, embedment, pain'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.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.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.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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.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.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.Unknown if the reported pain is directly related to the filter and unable to identify corresponding failure mode(s) at this time.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

Manufacturer reference # (b)(4).Investigation of 12jan2018 is still valid.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

Additional information received on 02jun2020: [patient] is now deceased.

Event Description

Additional information received alleges that the patient has subsequently expired.No allegation of wrongful death against the product has been received at this time.Per certificate of death dated (b)(6) 2019 "immediate cause of death: recurrent cholangiocarcinoma.Other contributing conditions: diastolic congestive heart failure, type ii diabetes, coronary artery disease and recurrent pulmonary embolism".

Manufacturer Narrative

Correction: d4 - lot # (mdr).Lot #e247056 reported in follow up #2 in error is an invalid lot #.Lot is currently unknown.Additional information: a1, b5 and b6.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.Catalog and lot numbers are unknown, however, the alleged tulip is manufactured and inspected according to specifications.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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, dk-4632; bjaeverskov
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov, IN 47404 ; 8004574500
• MDR Report Key: 5719736
• MDR Text Key: 47199897
• Report Number: 3002808486-2016-00506
• 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: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/07/2016
• Date Manufacturer Received: 10/05/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 129 KG