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

Catalog Number UNKNOWN

Device Problems Inadequate Filtration Process (2308); Structural Problem (2506); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Pain (1994); Perforation of Vessels (2135); Dizziness (2194); Ambulation Difficulties (2544); Swelling/ Edema (4577); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Catalog # is unknown but referred to as celect pt.Non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged celect pt 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.

Event Description

It is alleged that the patient received a cook celect platinum on (b)(6) 2014.It is alleged that the patient was injured without further explanation.The patient has reportedly expired.Specific details surrounding the patient's expiration are currently unknown, and there is no reported allegation of wrongful death at this time.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received an implant on (b)(6) 2014 due to post deep vein thrombosis (dvt) and pulmonary embolism (pe).Vena cava perforation is alleged.Further allegations include: shortness of breath, swelling, limited mobility, dizziness, pain, and post filter implant pe.The patient reportedly expired (b)(6) 2020; cause of death listed as septic shock due to febrile neutropenia.On (b)(6) 2016, per a report from computed tomography 2; ¿impressions: some of the filter struts have penetrated through the wall of the ivc into the pericaval/mesenteric fat.¿ per certificate of death, date of death was (b)(6) 2020, immediate cause of death is septic shock due to febrile neutropenia.Other significant conditions: end stage renal disease, non-ischemic cardiomyopathy, valvular heart disease, atrial fibrillation.

Manufacturer Narrative

Investigation: the following allegations have been investigated: pulmonary embolism, vena cava perforation, shortness of breath, swelling, limited mobility, dizziness, pain.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Unknown if the reported shortness of breath, swelling, limited mobility, dizziness, pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown.The alleged celect pt is manufactured and inspected according to controls.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 becomes 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

Per a report from computed tomography: "filter penetration: yes, see impressions." "impressions: some of the filter struts have penetrated through the wall of the ivc into the pericaval/mesenteric fat.See axial image 70/165." "addendum: cook celect filter.The anterior strut penetrates 8 mm through the ivc wall.Sagittal image 46.The left strut penetrates 8 mm through the ivc wall.Coronal image 55.The posterior strut penetrates 4 mm through the ivc wall.Sagittal image 43.The right strut penetrates 5 mm through the ivc wall.Coronal image 52.".

Manufacturer Narrative

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 number and lot number are unknown, however, the alleged celect-pt 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 medwatch report will be submitted if additional relevant information becomes 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, dk-4632; bjaeverskov
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 11498925
• MDR Text Key: 247014978
• Report Number: 3002808486-2021-00962
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White