MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135); Anxiety (2328); Disability (2371); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Initial reporter occupation: non-healthcare professional.(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that [pt] received a cook celect filter on (b)(6) 2017.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

Exemption number: e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Mfr site: name and address for importer site: cook medical incorporated (cmi) (b)(4).Device codes: appropriate term/code not available (3191): perforation.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.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

Additional information received identified the patient allegedly received an implant on (b)(6) 2017 via the right internal jugular vein due to deep vein thrombosis.The patient is alleging tilt, vena cava perforation, the device is unable to be retrieved and organ perforation.The patient further alleges, "i experience severe anxiety and physical complications caused by the inferior vena cava filter.The filter after two unsuccessful attempts can not be removed due to the device being tilted to the point where it cannot be retrieved.This has caused significant anguish to my life".Additionally, the patient alleges limited or no longer having the ability to lift weights for arm workout.Per the on (b)(6) 2018, retrieval report (unsuccessful): "procedure: a catheter was placed into the inferior vena cava and an inferior venacavogram was performed.The images obtained from this injection demonstrated persistent tilt of the inferior vena cava filter toward the patient's right.The apical approximates the wall with a small fibrous cap surrounding the hook.There is excellent flow through the inferior vena cava filter with no evidence of thrombus within or around the inferior vena cava filter.Using the retrieval device, multiple attempts were made to retrieve the inferior vena cava filter.However, due to the fibrous cap covering the apical hook, these attempts were unsuccessful.Findings: normal caliber inferior vena cava without intraluminal thrombus.There is excellent flow through the inferior vena cava filter which has a persistent tilt to the right.A fibrous cap covers the apical hook.Interventions: 1.Inferior venacavogram 2.Unsuccessful ivc filter removal".Per the on (b)(6) 2018, retrieval report (unsuccessful): "procedure: given the previous failed attempts at inferior vena cava filter removal with standard techniques, advanced techniques were initiated for this case.Over a guidewire a 14-french 45 cm vascular sheath was advanced into the inferior vena cava just superior to the inferior vena cava filter.Initial attempts were made to advance a regular glidewire just beneath the apex of the inferior vena cava filter and the wall of the inferior vena cava.However, these attempts were unsuccessful.What was demonstrated during this maneuver was that the patient has 2 renal veins on the right and the inferior vena cava filter apex appears to be tilted secondary the inferior accessory renal vein on the right.The second fall back maneuver was then elected.The 14-french vascular sheath was exchanged for an 18-french vascular sheath which was brought into position superior to the inferior vena cava filter.A regular glidewire was snared beneath the central portion of the inferior vena cava filter forming a large loop snare with the exchange length glidewire.This maneuver was successful in capturing the inferior vena cava filter struts superiorly.A 15 mm snare was then brought over the guidewire and directed toward the apex of the inferior vena cava.The snare again was unable to engage the apex and the hook of the inferior vena cava filter but the larger glidewire loop snare was secured at the conical portion of the filter.The 18-french sheath was then brought down into position and attempts were made to reposition the inferior vena cava filter to the central portion of the inferior vena cava.These attempts were ultimately unsuccessful.The third maneuver included utilization of a separate retrieval device that uses a mechanical cone and an angled guide sheath.The retrieval cone was brought into position at the upper third of the inferior vena cava.Again, the upper portion of the inferior vena cava filter was secured with the retrieval cone however at the apex and the could not be freed from the wall of the inferior vena cava/accessory right renal vein.This maneuver was also unsuccessful.Repeat inferior venacavogram demonstrated excellent flow in the inferior vena cava filter without evidence of thrombus formation.The apex of the inferior vena cava filter is without side of the central lumen of the inferior vena cava and it was felt that this position had minimal impact on flow dynamics within the inferior vena cava.I therefore elected to terminate the procedure and discuss leaving the inferior vena cava filter has a permanent device with the patient.Interventions: 1.Unsuccessful inferior vena cava filter removal using 3 advanced techniques.Impression: unsuccessful inferior vena cava filter removal using 3 advanced techniques.The tilt of the inferior vena cava filter appears to be related to an accessory renal vein on the right".Per the on (b)(6) 2018, computed tomography- abdomen and pelvis venogram with intravenous contrast: "impression: the inferior vena cava is free of thrombus as is the filter.3.Inferior vena cava filter appears to be intact however is distorted with 2 horizontally directed legs, one likely remains in the left renal vein with another that just slightly perforates the medial wall.The filter is tilted approximately 45 degrees laterally as well as mildly posteriorly.The hook of the filter is projected outside the wall of the inferior vena cava just caudal to the main right renal vein".

Event Description

No additional information provided at this time.

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged vena cava and organ perforation.Investigation ¿ the following allegations have been investigated: tilt, vc/organ perforation, unable to retrieve, anxiety, phys.Complications, anguish, disability.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Vena cava wall penetration/perforation has been reported and 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, vena cava perforation, vena cava penetration.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.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 anxiety, physical complications, anguish, and disability 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8398958
• MDR Text Key: 138092188
• Report Number: 3002808486-2019-00280
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/26/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 81