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

Catalog Number	IGTCFS-65-1-UNI-CELECT-PT
Medical Device Problem Codes	Difficult to Remove (1528); Obstruction of Flow (2423); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Pain (1994); Dizziness (2194); Numbness (2415); Thrombosis/Thrombus (4440); Cramp(s) /Muscle Spasm(s) (4521); Decreased Appetite (4569); Swelling/ Edema (4577); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It is alleged that the patient received a cook celect platinum inferior vena cava (ivc) filter on (b)(6) 2018.It is alleged that 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.E3: 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.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
510(k) - k211875.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: thrombus, device unable to retrieve, pain, swelling, numbness, cramp, dyspnea, appetite loss, dizziness, limited activity.The reported allegations have been further investigated based on the information provided to date.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.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications the filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Unknown if the reported pain, swelling, numbness, cramp, dyspnea, appetite loss, dizziness, limited activity is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.The associated work order was reviewed.No related/relevant notes were documented.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.
Event or Problem Description
It is alleged that patient received cook celect platinum inferior vena cava (ivc) filter on (b)(6) 2018 due to broken ankle with clotting followed by an unsuccessful, percutaneous retrieval attempt on (b)(6) 2018.The patient is alleging thrombosis and device is unable to be retrieved.Patient also experienced lower back and leg pain, leg/feet swelling, shortness of breath, loss of appetite, numbness in toes, dizziness, stomach swollen, cramping near groin area and limited activity.Per filter retrieval report (unsuccessful attempt): "findings: the hook of the patient's filter were not coming loose from the ivc and therefore we elected to leave the filter in place." per report from venogram: "preoperative diagnosis: thrombosis of the inferior vena cava with extensive bilateral lower extremity deep venous thromboses"."operation: 1.Bilateral lower extremity venogram and inferior venacavogram via ultrasound-guided bilateral popliteal venous access 2.Pta of the ivc, bilateral common iliac veins, bilateral external iliac veins, bilateral common femoral veins, and bilateral femoral veins using 8 mm mustang balloon 3.Placement of bilateral 50 cm ekos thrombolysis catheter extending from bilateral popliteal veins into suprarenal inferior vena cava".".The patient was transported to the cv sicu in stable condition".

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 17772908
• Report Number: 3002808486-2023-00241
• Device Sequence Number: 7219416
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)210321(10)E3705154
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/01/2023

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: 03/21/2021
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3705154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 95 KG