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

Model Number G52909

Device Problems Difficult to Remove (1528); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Perforation of Vessels (2135); Stenosis (2263); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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 # is unknown but referred to as celect.Occupation: non-healthcare professional.Catalog number and lot number are unknown, however, the alleged tulip 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 Description

Original.It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2010.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received an implant on (b)(6) 2010.The patient has reportedly expired.Currently, there is no reported allegation of wrongful death.

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.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.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: pulmonary embolism (pe), vena cava (vc) perforation, embedded, inferior vena cava (ivc) thrombosis/stenosis, unable to retrieve, migration, tilt, fear.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 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.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).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.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.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.Unknown if the reported fear 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-jug-celect) lot: e2619924, nor filter (igtf-30-celect) lot: e2618904 and e2617260.Two other complaints (pr31552, different issue, the filter had tilted, perforated, and one leg was raised caudally, which may have caused the pe to occur and pr183470, different issue, tilt, vc/organ perforation) 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 Description

Patient allegedly received an implant on (b)(6) 2010 via the right internal jugular vein due to deep vein thrombosis (dvt).Patient is alleging embedded filter with failed removal attempt, vena cava perforation, tilt.Patient further alleges "fear that the filter might cause further damage as it has not yet been removed." 28feb2011 unsuccessful retrieval report: per ct report, "it appears that there has been slight filter migration in the interval.The filter is more slightly positioned cephalad within the ivc and there is a leg on the left side which is elevated and likely perforating the left lateral wall of the cava.These findings likely reduce the effectiveness of the filter entrapping emboli and it is my understanding after speaking [physician] that the patient has had recurrent emboli since filter placement.In light of these findings, i would consider retrieval of this filter and replacement of a new filter which is better aligned with the cava.If the present filter cannot be retrieved, then i would consider placing a second filter caudle to it." per retrieval report (attempted): "the patient has a previously placed cook select filter.This has tilted and migrated slightly likely affecting its filtering ability.The patient has had a recurrent p.E.In the interval." "this demonstrates tilting of the filter with the apex and retrieval hook of the filter abutting the right lateral wall of the cava.The cava is normal in course and caliber.Cable thrombus or thrombus within the ivc or ivc filter are not identified.The cook recovery snare was advanced to the filter.Multiple attempts were made to engage the hook within the snare, however, could not be captured due to apparent ingrowth into the wall of the cava." "it is likely that the hook could not be completely freed from the caval wall.After approximately 16 minutes of fluoro time, a decision was made to abandon further attempts at retrieving this filter and place a second filter.The retrieval device was removed over a guidewire.A 12 french sheath was placed at the right ij puncture site.A second cook select filter was then advanced and deployed just below the first filter." per ct report, "there were 2 vena cava filters in the ivc, both below the level of the renal veins.The contrast bolus was suboptimal, with decreased density within the ivc below the level of the filters, which could be due to the influx of contrast from the kidneys.There was mild soft tissue density stranding within the retroperitoneal fat adjacent to the abdominal aorta and ivc.Developing ct evaluation of the pelvis showed no mass, adenopathy or ascites.The right external iliac vein was decreased in size relative to the left external iliac vein, with possible decreased density within the lumen." per ct report, "there are 2 inferior vena cava filters placed within the infrarenal cava.Dual right and single left renal veins are seen forming a confluence with the inferior vena cava at the level of l2.The superior inferior vena cava filter is seen with its tip 10 mm below the lowest renal vein, best seen on coronal image #68.The superior filter demonstrates approximately 15 degrees of right lateral tilt with its tip opposed to the right lateral sidewall of the ivc.Since prior examination, strut penetration has progressed, though the struts appear to extend only into the retroperitoneal fat surrounding the cava at the 1:00 to 6:00 positions and appears to extend into the origin of the right gonadal vein at the 12:00 position." "the inferior most vena cava filter extends into the filter region of the superior filter, best seen on coronal image #69.While there is no significant tilt, curvature of the vena cava at this level results in apposition of the filter tip and retrieval hook to the right lateral sidewall.There is minimal strut penetration at the 1:00 position into the retroperitoneal fat only.There has been progressive narrowing of the inferior vena cava at the caval confluence at the juncture of the inferior most vena cava filter struts suggesting caval thrombosis at this level.While this is difficult to confirm without contrast administration, the common iliac veins are all relatively narrow caliber and there are progressively dilated abdominal wall collaterals identified likely representing antegrade venous collaterals.".

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a5a, a5b, b5, b6 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.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 the 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 certificate of death: immediate cause: respiratory arrest, combined congestive heart failure, stage 4 kidney disease, severe chronic obstructive pulmonary disease.

• 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, dk-4632; bjaeverskov
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 11586486
• MDR Text Key: 242913202
• Report Number: 3002808486-2021-01040
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529097
• UDI-Public: (01)10827002529097(17)130714(10)E2619924
• 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,Followup,Followup
• Report Date: 08/12/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: G52909
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Device Lot Number: E2619924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 03/30/2022; 05/24/2022; 07/21/2022
• Supplement Dates FDA Received: 04/11/2022; 06/20/2022; 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2010
• 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 Sex: Male
• Patient Weight: 154 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White