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

Catalog Number UNKNOWN

Device Problems Obstruction of Flow (2423); Structural Problem (2506); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Depression (2361); No Information (3190); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Name and address for importer site: (b)(4).Since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter implanted 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).Corrected data based on new information received: adverse event to product malfunction, serious injury to malfunction.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 06/26/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the due to dvt.Plaintiff is alleging tilt, vena cava perforation, atrial fibrillation, heart problems, breathing issues, leg pain, leg swelling, fluttering heartbeat, abdominal pain, pain in side, anxiety, depression, sharp chest pain, headaches, sleep disorder.

Manufacturer Narrative

Manufacturer reference #: (b)(4).Exemption number e2016032.(b)(4).Corrected data based on new information received: serious injury to malfunction.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 'tilt, vena cava perforation, atrial fibrillation, heart problems, breathing issues, pain, anxiety'.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 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 atrial fibrillation, breathing problems, heart problems, pain, anxiety, and depression are directly related to the filter and unable to identify a corresponding failure mode 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

Per operative note (filter implantation), dated (b)(6) 2015, "the left common femoral vein was accessed.Celect filter was deployed without difficulty." per abdominal ct, dated (b)(6) 2016, "there is an inferior vena cava filter noted.There is mild tilt of the filter with the apex towards the right, however, it does appear appropriately positioned within the infrarenal ivc.No pericaval inflammatory changes or fluid collection.Evaluation for intrafilter caval thrombus is limited due to the lack of contrast.Well-positioned infrarenal ivc filter.Without evidence of complication.".

Manufacturer Narrative

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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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 its 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.

Event Description

Patient allegedly received an implant on (b)(6) 2015.Multiple prongs of the filter have perforated patient inferior vena cava.One prong has further perforated patient¿s aorta.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation is reopened due to additional information provided.The following allegations have been investigated: aorta perforation.The reported allegations have been further investigated based on the information provided to date.The additional information regarding aorta perforation does not change the previous investigation results for vena cava perforation.Catalog and lot number are unknown, but the select filter 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a4, b5, b6, b7, h6.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ perforation, deep vein thrombosis (dvt), depression, bipolar disorder, worry, limited physical activity.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation does not change the previous investigation results for aorta and vena cava perforation.Ivc occlusion/ thrombosis, new dvt, ivc stenosis 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: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported depression, bipolar disorder, worry, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot number are unknown, but the celect filter 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.

Event Description

Patient is alleging organ perforation.Patient further alleges "multiple prongs of the ivc filter implanted in my body have perforated my ivc.Further, one prong of the filter is perforating my aorta.I live with the anxiety of having a filter that could fail further at any time, but that cannot be retrieved without a serious surgery.I am worried because my filter has perforated outside of my vena cava into another organ." "i try not to engage in any activities that cause me to exert myself" as well as bipolar disorder and post filter implant deep vein thrombosis (dvt).Per computed tomography report, "a total of (b)(4) prongs have perforated through ivc.Maximum distance prong perforated through ivc is 6.28mm." "coronal image show 8.70-degree tilt of filter left-to-right.Sagittal images show 3.04-degree tilt anterior-to-posterior." "diameter of ivc directly above filter measures 26.23mmx 8.28mm." "prong has perforated aorta".

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov, IN 47404 ; 8004574500
• MDR Report Key: 6636114
• MDR Text Key: 77397388
• Report Number: 3002808486-2017-01278
• 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: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• 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
• Distributor Facility Aware Date: 05/26/2017
• Date Manufacturer Received: 06/27/2022
• 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: 116 KG