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

Catalog Number IGTCFS-65-1-JUG-CELECT

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Device Tipped Over (2589); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Blood Loss (2597); No Information (3190); Thrombosis/Thrombus (4440)

Event Date 08/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Name and address for importer site: (b)(4).Pma 510(k): since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6)2013".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 09/14/2017 as follows: patient received an implant on (b)(6) 2013 via the right internal jugular vein due to trauma.Patient experiences caval penetration and hematuria.Patient is alleging device migration, organ perforation, pain and bleeding due to the device.Patient alleges additional surgery required was required due to the device.Successful device retrieval on (b)(6) 2015.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'vc perforation, organ perforation, hematuria, migration, bleeding, pain, difficult to retrieve (surgery)'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported hematuria, bleeding and pain are directly related to the filter and unable to identify a corresponding failure mode at this time.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.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.

Event Description

Per additional information received the celect filter was implanted on (b)(6) 2013.

Event Description

Additional information received 18nov2022: per a medical opinion report: "date of ivc filter placement: (b)(6) 13 device: cook celect findings: review of the medical documentation revealed that [patient name] underwent the successful infrarenal placement of a cook celect retrievable inferior vena cava filter system on (b)(6) 2013.A review of the medical documentation, including the final radiology report of a ct scan of the abdomen and pelvis performed on or about (b)(6) 2015, revealed an indwelling ivc filter noted to be penetrating the ivc wall and the right ureter in images 48 and 49 of series 5.Furthermore, the medical documentation stated that [patient name] had contemporaneous complaints of hematuria.There is no measurement of this, or any, ivc filter component penetrations, as well as, no comments made regarding any ivc filter angulation, position, migration or the presence of component fractures.However, in the absence of these measurements, any ivc filter component extending beyond the perceptible wall of the ivc that perforates an adjacent structure (and specifically the right ureter in this case) is, by definition, and more likely than not, a grade 4 pathologic ivc filter component penetration extending greater than 3 mm beyond the perceptible wall of the ivc within a reasonable degree of medical probability.Subsequently, this indwelling ivc filter was successfully retrieved on (b)(6) 2015".Per additional information received 25feb2019: successful filter retrieval: "findings: initial venogram demonstrates a patent ivc, without evidence of thrombus or anomaly.However, there is significant narrowing of the cava at the level of penetration.There was no extravasation.The celect ivc filter is seen in an infrarenal position with a slight posterior tilt.Follow-up venogram status post filter retrieval demonstrates no evidence of contrast extravasation or fistulization to the right ureter.There are a number of collateral vessels originating from the right common iliac vein due to narrowing and vessel wall irregularity at the level of penetration.There is a small portion of more normal cava below the level of the renal veins, just above the area of penetration"."impression: successful retrieval of ivc filter".Computed tomography (ct): " no evidence of pulmonary embolism.An ivc filter leg appears to extend into the lumen of the right proximal ureter." x-ray: " an ivc filter leg appears to extend into the lumen of the right proximal ureter.

Manufacturer Narrative

Upon further review, it was noted additional information noted received on 25feb2019 was not submitted in a follow up mdr at the time; therefore, the information is being included as a correction in this follow up report.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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: narrow inferior vena cava (ivc), tilt.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 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.Catalog and lot number is unknown however, the alleged celect is manufactured and inspected according to controls.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 Description

Per a report from computed tomography (ct), "impression: 1.Ivc filter noted at level of l2.Extensive filling defect is noted in the inferior vena cava at the level of the ivc filter extending inferiorly into the right common iliac and internal iliac veins and into the right common femoral vein compatible with extensive deep vein thrombosis.Associated moderate adjacent fat stranding of the level of the ivc bifurcation and proximal common iliac veins.2.Suspect filling defect and deep vein thrombosis within the left common iliac vein as well".

Manufacturer Narrative

Additional information: b5, b6 and h6.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: deep vein thrombosis.The reported allegations have been further investigated based on the information provided to date.The additional information regarding deep vein thrombosis does not change the previous investigation results for narrow ivc.Catalog number is known and lot number is 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.

• Brand Name: NAVALIGN COOK CELECT JUGULAR 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, IN 47404 ; 8004574500
• MDR Report Key: 6840832
• MDR Text Key: 84617314
• Report Number: 3002808486-2017-01727
• Device Sequence Number: 1
• Product Code: DTK
• 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: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/05/2023

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 Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/21/2017
• Initial Date Manufacturer Received: 08/19/2017
• Initial Date FDA Received: 09/04/2017
• Supplement Dates Manufacturer Received: 09/14/2017; 10/02/2017; 04/01/2021; 11/08/2022; 11/08/2023
• Supplement Dates FDA Received: 09/21/2017; 10/05/2017; 04/19/2021; 11/28/2022; 12/05/2023
• 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
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 93 KG