MAUDE Adverse Event Report: WILLIAM COOK EUROPE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G52909
Medical Device Problem Codes	Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Stenosis (2263); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2014, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a2, a4, b1, b5, b6, b7, d1, d4, g4, h4, and h6.Additional information: investigation investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava perforation, thrombosis, stenosis, tilt, chest pain, dyspnea.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: vascular trauma, vena cava perforation, vena cava penetration.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.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported chest pain, dyspnea is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.The product 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.
Event or Problem Description
Patient allegedly received an implant on (b)(6)2014 via the right internal jugular vein due to prior pulmonary embolism (pe).Patient is alleging chest pain and shortness of breath.(b)(6)2014 report from venogram: "findings: inferior venacavogram demonstrates ivc filter in place.There does appear to be thrombus adherent to the ivc filter.No thrombus in the right external iliac or common iliac veins is identified.There is thrombus extending from the popliteal vein up through the common femoral vein"."thrombolytic infusion was initiated with placement of a unifuse catheter.Anticipate repeat venogram tomorrow".(b)(6)2014, report from venogram: "there is near complete thrombolysis of the right femoral popliteal deep venous thrombus previously identified.There is mild residual nonobstructing thrombus in the cephalad aspect of the femoral vein, approximately 2 cm in length.No other residual thrombus.There is moderate 5-6 cm length 50-60% stenosis in the distal right femoral vein near its junction with the suprageniculate popliteal vein.No other significant femoral vein stenosis.No common or external iliac vein stenosis.Inferior vena cava filter within the ivc is noted, somewhat tilted." (b)(6)2020, report from ct: "filter type: cook.Ivc stenosis: none.Filter position: below the renal veins.Filter migration: none.Filter fracture/bending: no.Filter tilt: yes.Filter penetration: yes, see impressions.Other findings: no.Impressions: the tilter [sic] is tilted such that the proximal cone is against the right side wall.A left sided strut is 15mm through the ivc wall, coronal image 89.A posterior strut is 10 mm through the ivc wall, coronal image 111.An anterior strut is 7 mm through the ivc wall, sagittal image 112.".
Event or Problem Description
Additional event information received.It is reported that the patient expired on (b)(6) 2022, however no allegation of wrongful death has been made at this time.Patient's representative is alleging vena cava perforation and organ perforation.They further allege pain.Report from ct (computed tomography): "filter type: cook celect.Ivc stenosis: no.Filter position: below the renal veins.Filter migration: none.Filter fracture/bending: no.Filter tilt: no.Filter penetration: yes.Other findings: yes.Impressions: the filter is not tilted but the cone of the filter is against the posterior right wall of the ivc.Axial image 43.The anterior strut penetrates 7 mm through the ivc wall.It penetrates into the right common iliac artery.Sagittal image 112.The left strut penetrates 15 mm through the ivc wall.Coronal image 89.The posterior strut penetrates 8 mm through the ivc wall.Sagittal image 110.The right strut penetrates 7 mm through the ivc wall.Coronal image 86." death certificate: causes of death: pneumonia, covid-19.
Additional Manufacturer Narrative
Additional information: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: artery perforation, pain.The additional information regarding artery perforation does not change the previous investigation results for vena cava perforation.Unknown if the reported pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.The product 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: NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14848138
• Report Number: 3002808486-2022-00871
• Device Sequence Number: 20019655
• Product Code: DTK
• UDI-Device Identifier: 10827002529097
• UDI-Public: (01)10827002529097(17)161021(10)E3146233
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2016
• Device Model Number: G52909
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Device Lot Number: E3146233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/30/2022; 10/18/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/14/2022; 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American