MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Arrhythmia (1721); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.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

It is alleged that "[pt] received a cook celect filter on (b)(6) 2016".It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

The patient allegedly received an implant on (b)(6) 2016 due to injuries sustained from [an] accident.The patient is alleging embedment, tilt, and that the device is unable to be retrieved.The patient is further alleging irregular heartbeat and limited physical activity.The patient reportedly underwent an unsuccessful filter retrieval approximately 8 months later due to the filter no longer being needed.Per an attempted retrieval report, "the patent's inferior vena cava showed evidence of prior thrombus presence, with some postphlebitic change in the left common iliac vein and within the inferior vena cava.[the physician] was unable to dislodge the ivc filter from the caval walls.After several attempts at retrieval, the procedure was terminated.The patient tolerated the procedure well, and there were no complications encountered.".

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.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.

Manufacturer Narrative

The reported allegations have been further investigated based on the information provided to date.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.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.Unknown if the reported irregular heartbeat and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes in work order.Device is manufactured and inspected according to current 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 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

No additional information has been provided at this time.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8784022
• MDR Text Key: 150815090
• Report Number: 3002808486-2019-00985
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3392028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 136