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

Catalog Number UNKNOWN

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems Pain (1994); Perforation (2001); Perforation of Vessels (2135); Injury (2348); Chest Tightness/Pressure (2463); Blood Loss (2597)

Event Date 03/27/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Description according to complainant: it is alleged that "on or about (b)(6) 2011, [pt] had a cook gunther tulip ivc filter implanted (b)(6) pursuant to a doctor's order.On or around (b)(6) 2012, [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." patient outcome: 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).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook günther tulip filter.Expiration date: unknown as lot# is unknown.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, which patient allegedly suffered approx.3 months after placement of a tulip filter, because the filter became "imbedded, tilting, migrating, fracturing, perforating [pt], and/or otherwise becoming irretrievable." 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).Fracture of filter legs is a known risk reported in the published scientific literature.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.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) 2011, [pt] had a cook gunther tulip ivc filter implanted in the state of (b)(6), pursuant to a doctor's order.On or around (b)(6) 2012, [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." patient outcome: 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 11/14/2017 as follows: patient received an implant on (b)(6) 2011 via the left common femoral vein due to right lower extremity deep venous thrombosis, status post pulmonary embolism in the past with inability to be anticoagulated.Patient is alleging tilt; vena cava perforation, bleeding, pain, fatigue, pain in chest due to the device.Patient alleges that the device is unable to be retrieved.Retrieval was attempted on (b)(6) 2012.

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 'tilt, vena cava perforation, bleeding, device unable to be retrieved, pain, fatigue, tight pain in chest'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 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.Unknown if the reported bleeding, fatigue 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.

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) 2020: "immediate cause of death: pending further study".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 number and lot number 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: 5513186
• MDR Text Key: 41147190
• Report Number: 3002808486-2016-00120
• 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: 03/21/2016
• 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
• Is the Reporter a Health Professional?: No
• 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): Other; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White