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

Model Number	G52914
Medical Device Problem Codes	Obstruction of Flow (2423); Structural Problem (2506); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Dyspnea (1816); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Numbness (2415); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Hyperresponsive to stimuli (4538); Swelling/ Edema (4577); Peripheral Edema (4578); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: 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.
Event or Problem Description
It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2012, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
Additional Manufacturer Narrative
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: organ/vena cava perforation.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.Catalog and lot numbers 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 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 or Problem Description
Per a ct abdomen/pelvis: "findings: filter type: cook celect.Ivc stenosis: no.Filter position: below the renal veins.Filter migration: no.Filter fracture/bending: no.Filter tilt: no.Filter penetration: yes.Other findings: yes.Impressions: the anterior strut penetrates 9 mm through the ivc wall.Sagittal image 118.The left strut penetrates 2.7 mm through the ivc wall.Coronal image 85.The posterior strut penetrates 7 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes.Sagittal image 118.The right strut penetrates 10 mm through the ivc wall.Coronal image 85".
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, 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.The following allegations have been investigated: pulmonary embolism (pe), organ/vena cava (vc) perforation, deep vein thrombosis (dvt), occlusion, leg swelling, pain/sensitivity, numbness, copd (chronic obstructive pulmonary disease), colon perf, gallbladder removal, sob (shortness of breath), depression, anxiety, limited physical activity.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.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 leg swelling, pain/sensitivity, numbness, copd (chronic obstructive pulmonary disease), colon perforation, gallbladder removal, sob (shortness of breath), depression, anxiety, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.No other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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 or Problem Description
Patient allegedly received a select filter via the femoral vein due to pulmonary embolism (pe).Patient is alleging vena cava and organ perforation.Patient notes and further alleges experiencing "leg swelling, weeping fluid from rt leg, painful sensitivity, lower + mid back pain, numbness, respiratory issues copd, perforated colon emergency surgery, removed gallbladder [sic], diastasis recti-abdominal separation surgery, major complications from surgery ie.6 weeks on ventilator + very large abdominal open wound 9'' x 15'' and wound vac therapy for 8 months", limited activity, shortness of breath, depression, anxiety, and pe after filter placement.Per a ct abdomen: "ivc filter findings: filter tilt: filter is essentially oriented along the long axis of the ivc.Filter position: tip of the filter is approximately 2.6 cm below the lowest (the right) renal vein.Filter perforation: no definitive filter perforation appreciated.Filter strut fracture or bending: none appreciated.Ivc stenosis: the ivc appears occluded at the level the filter and just below with calcifications probably representing chronic based thrombus within the filter, extending into the distal ivc and common iliac veins which appear occluded.Numerous collaterals noted".

• Brand Name: COOK CELECT NAVALIGN FEMORAL 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: 15745206
• Report Number: 3002808486-2022-01014
• Device Sequence Number: 7074983
• Product Code: DTK
• UDI-Device Identifier: 10827002529141
• UDI-Public: (01)10827002529141(17)150914(10)E2978834
• 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: 2012
• 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): 05/22/2023

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: 09/14/2015
• Device Model Number: G52914
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2978834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 03/01/2023; 04/25/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 03/17/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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
• Patient Sex: Female
• Patient Weight: 104 KG