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

Device Problems Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Depression (2361); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Section 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.20 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 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 Description

It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2011.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

The patient received celect inferior vena cava (ivc) filter on (b)(6) 2011 via right femoral vein due to deep vein thrombosis (dvt) and pulmonary embolism (pe).The patient is alleging device fracture, organ/vena cava perforation, and migration.The patient further alleges experiencing dvt and pe post filter placement, groin pain, depression, anxiety and limited activity.Patient allegedly received a second, non-cook, ivc filter (b)(6) 2012 due to thrombus surrounding the cook filter and recurrent pe.It is alleged patient required a thrombectomy procedure to remove clotting in the ivc.Per an angiogram report: "impression: 1.Age-indeterminate left upper lobe pulmonary embolism is new from the prior examination.There has been interval placement of an ivc filter.There is a small residual right basilar segmental pulmonary embolism in all of the additional pulmonary emboli are no longer seen".Per a computed tomography (ct) angiogram report: "findings: an ivc filter is present"."impression: 1.Significant interval increase in pulmonary emboli.There is a new large right main pulmonary embolism with extension into all three lobar vessels and several new segmental pulmonary emboli are also present".Per a report from venogram: "procedure description/findings: there was thrombus evident surrounding the ivc filter.There appeared to be significant thrombus around and above the filter, giving evidence for recurrent pulmonary embolus.At this point in time, using ultrasound guidance, the right jugular vein was accessed with a micro puncture needle and a bard jugular eclipse filter was subsequently brought into the field.The dilator and sheath were placed into position.Position was just above the prior ivc filter, which was at the level of the renal veins.The cava was of appropriate size.The filter was then introduced into the sheath and deployed in its typical fashion without any complications.A final venogram showed excellent position".Per a report from thrombectomy: "procedure indications/description/findings: [patient] hospital course was complicated by recurrent pulmonary embolus requiring a second ivc filter above [the] first filter, where there was thrombus collected on the filter.The patient had a hit complication and needed argatroban for anticoagulation.This is probably apart [sic] of [patient's] thrombosis of [the] vena cava and ivc filter"."there was thrombus within the distal inferior vena cava going up to [the] ivc filter.At this point in time, an angiojet was brought into field and 10 mg of tpa was applied locally to the thrombus.We waited 20 minutes and then did an angiojet thrombectomy of the clot.Final angiographic pictures much improved flow through the vena cava".Computed tomography (ct) report: "findings: there is nonocclusive thrombus in the ivc and left common femoral vein.Two suprarenal ivc filters are present".Per a computed tomography (ct) report: "findings: suprarenal ivc filters are in unchanged position"."dvts are present in both common femoral veins".Per a report from computed tomography (ct): "two ivc filters: upper filter above the renal veins with: tilting with the apex against the ivc wall, 11 mm mesenteric, 10 mm aortic, and 9 mm liver perforation, no fracture, stenosis, or migration.Lower filter with: tilting with the apex against the ivc wall, 6 mm mesenteric, 8 mm vertebral, and 16 mm left renal vein perforation, a fractured strut, the filter is located across the renal veins, which may represent migration, no stenosis".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: pulmonary embolism, fracture, organ/vena cava/renal vein perforation, thrombus, migration, tilt, groin pain, depression, anxiety and limited activity.The reported allegations have been further investigated based on the information provided to date.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 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 groin pain, depression, anxiety and 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.

• Brand Name: COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
• Type of Device: 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: 17809110
• MDR Text Key: 324157542
• Report Number: 3002808486-2023-00248
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529141
• UDI-Public: (01)10827002529141(17)141010(10)E2814493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2014
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2814493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Weight: 65 KG