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

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problems Break (1069); Retraction Problem (1536)

Patient Problems Great Vessel Perforation (2152); Foreign Body In Patient (2687)

Event Date 09/07/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device marketed under pma/510(k) k211875.Investigation is still in progress.This report is required by the fda under 21cfr 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

Description of event according to initial reporter: this filter had been lost to follow up over the years and had been in over 10 years.Vs decided it needed to come out as 3 of the legs of the filter had perforated the ivc.Ivc filter was removed via normal retrieval procedure with the gtrs-200-rb.Filter was very difficult to remove and inserted a balloon over an ultra striff amlpax wire to help centre the retrieval hook in the ivc to be retrieved.Ivc filter was retrieved however one leg remain lodged in the ivc.This leg was not mobile and the physician felt this was not a problem due to how long the filter had been insitu.No further procedure was required and the patient was stable.Patient outcome: no additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Investigation is still in progress.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 on 12sep2022: yes the filter fractured during removal.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: a celect-pt filter had been in for over 10 years was observed with 3 legs that had perforated the ivc.The physician decided that the filter needs to be removed.The filter was retrieved but one leg remained lodged in the ivc.The physician decided to leave the leg as it was due to how long it has been in situ.No further procedure was required, and the patient was reported stable.A single ct image, along with the complaint report, were submitted for review.Per the complaint report, the ivc filter had a dwell time of greater than 10 years.The filter was no longer clinically indicated, and removal was recommended due to penetration of at least 3 of the primary filter legs.No images were submitted prior to retrieval of the ivc filter, nor were there any images submitted from time of ivc filter placement.The only image submitted for review demonstrates a single remaining primary filter leg extending through the anterior inferior aspect of a lumbar vertebral body without clear extension into the inferior vena cava.This leg was fractured during the retrieval event, and the retrieving physician felt this remaining leg would have little risk of "a problem".Without images demonstrating the orientation of the ivc filter, and the patient's anatomy, it is difficult to determine the exact cause of the perforation as described.The cause of ivc filter penetration is likely multifactorial.Dwell time, significant filter tilt, and ivc diameter measuring less than 24 mm have been described as potential contributing factors to development of ivc filter penetration.Despite this, the resultant fracture of a primary filter leg during retrieval is likely contributed to the fixation of the primary filter leg as it extended through the vertebral body resulting in significant alteration of forces at the attachment point of this primary filter leg.Given the long dwell time, and the repeated micromovement of the filter with respiration and abdominal movement, this resulted in metal fatigue directly contributed to weakening of the primary filter leg and during retrieval, this contributed to the fracture of the primary filter leg.Although there are many case reports utilizing endobronchial forceps to retrieve these fractured primary filter legs that are perforated into adjacent structures, given this leg is embedded in the vertebral body, it's believed that it poses little to no significant risk.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.According to the instruction for use potential adverse events that may occur include, but are not limited to, the following: filter fracture, vena cava perforation.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Cook medical will continue to monitor for similar events.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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15378747
• MDR Text Key: 299458519
• Report Number: 3002808486-2022-00944
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2022

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 Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 11/01/2022
• Supplement Dates FDA Received: 09/15/2022; 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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