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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Retraction Problem (1536)

Patient Problems Great Vessel Perforation (2152); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  Injury  

Event Description

Description of event according to initial reporter: (b)(6) 2021: celect filter retrieval.Two physicians already attempted retrieval.A third physician has now attempted.The hub-hook was embedded in the wall of the ivc above left renal.Internal jugular (ij) access and right groin access.Used bronchial forceps to retrieve filter from the wall.Bronchial forceps through ij to pull filter off of the wall of the ivc.Used a glidewire and angeled catheter from the ij to do the ¿hangman¿ technique and get the filter off the wall.Used bronchial forceps from the groin to get the filter off the wall.Did both hangman technique from above and bronchial forceps from below to dislodge filter and was finally successful.The filter was then turned sideways.The third physician used the bronchial forceps to angel the hook caudal and retrieve the filter from the groin with a large bore 18 fr sheath.Dislodge filter at the same time.From ig used bronchial forceps to retrieve filter again, fractured a primary leg off the of filter.Device only had 7 legs upon retrieving, remaining leg was not found or retrieved.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook celect filter.Investigation is still in progress.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that the celect filter had already tried to be retrieved twice, this was the third attempt.The filter was tilted, and the hook was embedded in the ivc wall ((b)(4)- fda mfg report# 3002808486-2021-01988).The physician used advanced retrieval technique to retrieve the filter which included bronchial forceps.During the retrieval the filter fractured, and a leg separated from the filter.It was reported that no parts of the device remains in the patient ((b)(4) - fda mfg report#).One single venographic image was provided for imaging review.Per imaging review: the complaint report does state the dwell time was > 10 yrs, and no images of the placement were submitted for review.The single image submitted for review demonstrates a celect ivc filter with a significant leftward tilt and perforation of the cranial 20 mm of the ivc filter as well as perforation of multiple secondary and primary legs.The ivc filter hook perforates above the level of the left renal vein ostium.Without the placement images, it cannot be determined if this tilt and location is a change or if the filter was placed in this configuration, or if it has changed with each of the subsequent retrieval attempts.Ivc filter perforation is often multifactorial, dependent on patient¿s anatomy/physiology but has also been shown to be associated with longer dwell times, ivc filter tilt and a small diameter ivc.In this case, the patient has all three potential contributing factors.Retrospectively determining if the tilt led to the perforation or if the perforation led to the tilt is not possible given the little data included in this complaint.Importantly, the filter was retrieved on the third attempt, using some advanced filter retrieval techniques from a femoral and jugular approach.Unfortunately, while retrieving the filter, reportedly only 7 secondary legs were attached to the retrieved ivc filter, indicating one fractured during the retrieval.The report states that the filter leg was not found and it is uncertain if the leg is still in the patient.A ct scan should be entertained to exclude migration/embolization of the secondary leg.Given the degree of manipulation required to retrieve the filter, and the configuration of the ivc filter prior to retrieval, the fractured secondary filter leg was likely caused by metal fatigue related to the abnormal repetitive forces placed on the filter legs and not necessarily a manufacturing defect.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.There are adequate controls in place to ensure that this type of device is manufactured to specifications.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: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.The product was not returned and with the information provided it is unknown what caused the filter to tilt and the filter to perforate the ivc.It has been reported that one filter leg couldn´t be found and no parts og the filter was left in the patient.If there is any doubts whether or not the filter leg was retrieved a ct scan could be considered.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: UNKNOWN
• 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: 12922332
• MDR Text Key: 281651183
• Report Number: 3002808486-2021-01989
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• 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): Required Intervention