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	Aneurysm (1708); Perforation of Vessels (2135); Thrombosis/Thrombus (4440); Pulmonary Hypertension (4460); Swelling/ Edema (4577); 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) 2012, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
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.
Event or Problem Description
Patient allegedly received an implant on (b)(6) 2012 via the common femoral vein due to deep vein thrombosis (dvt).Patient is alleging vena cava perforation.Patient further alleges "aneurysm of ascending aorta.History of venous thromboembolism.Pulmonary hypertension.Left ventricular hypertrophy (lvh).Bilateral leg edema." "cardiovascular rehab without chest pain".Per computed tomography (ct) report, "there is thrombotic expansion of the bilateral popliteal, femoral, and bilateral iliac and the ivc.The ivc thrombus extends up to the region of the ivc filter with mild associated perivascular stranding.There is 1.9 cm proximal extension of the thrombus into the segment of the ivc proximal to the tip of the ivc filter." "there is contrast opacification of the ivc proximal to the ivc filter and in the intrahepatic portion.The ivc greenfield filter is seen is seen at the level of the l2 vertebra with the tip seen adjacent to the ll-l2 disc space." per ct report, "there is an ivc filter.There is a vascular stent extending from the distal portion of the ivc into the left common iliac vein." per ct report, "the filter is vertically oriented and the upper tip is located at the confluence of the left renal vein and ivc.The larger metallic struts project outside of the ivc wall by 7-8 mm in length and 4-5 mm in the transverse plane." "the ivc appears normal in caliber proximally, measuring 2.9x2.0 cm.This tapers to 1.5x1.5 cm at and below the level of the filter.There is a stent originating in the left common iliac vein and extending into the distal ivc.The proximal end of the filter abuts the right ivc wall.".
Additional Manufacturer Narrative
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, thrombosis, aneurysm, pulmonary hypertension, left ventricular hypertrophy (lvh), bilateral leg.The reported allegations have been further investigated based on the information provided to date.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.Unknown if the reported aneurysm, pulmonary hypertension, left ventricular hypertrophy (lvh), bilateral leg is directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) in lot.No relevant notes on wo for neither device (igtcfs-65-1-fem-celect) lot: e2950442, nor filter (igtf-30-celect) lot: e2944868 and e2944725.No other complaints on lots.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 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: COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
• Common Device Name: 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: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14496932
• Report Number: 3002808486-2022-00741
• Device Sequence Number: 14957372
• Product Code: DTK
• UDI-Device Identifier: 10827002529141
• UDI-Public: (01)10827002529141(17)150723(10)E2950442
• 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
• Report Date (Section B): 06/22/2022

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: 07/23/2015
• Device Model Number: G52914
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2950442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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: Male
• Patient Weight: 109 KG