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

Catalog Number	IGTCFS-65-1-FEM-CELECT
Medical Device Problem Codes	Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Ulcer (2274); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Swelling/ Edema (4577); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: the following allegations have been investigated: fracture, organ/vena cava (vc)/aorta perforation, stenosis/occlusion/caval thrombosis, migration, tilt, fluid retention, swelling, ulcers, required wound care, limited activity, pain, anxiety, depression.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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 fluid retention, swelling, ulcers, required wound care, limited activity, pain, anxiety, and depression are 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 work order.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
The patient allegedly received an implant (b)(6) 2012 via the right common femoral vein due to post deep vein thrombosis (dvt).The patient alleges migration, vena cava perforation, fracture, organ perforation, stenosis, and caval thrombosis.The patient further alleges a broken strut, aorta perforation/vein causing excess fluid in legs, leg swelling/ulcers, required wound care to heal wounds, limited activity, pain, anxiety/depression.Percutaneous filter removal on (b)(6) 2021 due to complications/injuries.06may2021, per a report from computed tomography; "there is an ivc filter in place with marked stenosis or possibly occlusion of the infrarenal ivc near the juncture of the right and left common iliac veins"."there is a fractured limb in the soft tissue immediately adjacent to the renal pelvis and proximal ureter".¿ivc filter in the infrarenal ivc is fractured with several feet extending into surrounding structures as described above including the right common iliac artery.There is occlusion of the infrarenal ivc with extensive abdominal wall venous collateral channels.¿ 28oct2021, per a report from retrieval report (successful); ¿successful removal of partially thrombosed infrarenal ivc filter following 9 year 9 month dwell time.Filter elements penetrated the right common iliac artery, but following filter removal there was no evidence of arterial injury.2.Technically successful endovascular reconstruction of chronic ivc and iliofemoral venous thrombotic disease.¿.

• 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: 17009558
• Report Number: 3002808486-2023-00157
• Device Sequence Number: 7668620
• Product Code: DTK
• UDI-Device Identifier: 10827002529141
• UDI-Public: (01)10827002529141(17)141121(10)E2835399
• 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
• Device Explanted Year: 2021
• 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): 07/28/2023

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: 11/21/2014
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2835399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2011
• 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