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

Catalog Number UNKNOWN

Device Problem Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.Pma/510(k): k172557.Investigation is still in progress.

Event Description

They were able to snare the filter with a clover snare and advance the inner and outer sheath to collapse the filter.They made it all the way down to the feet of the filter, but could not collapse the feet into the sheath.They made several attempts but could not get the feet off the wall of the vena cava.At that point, the physician elected to end the procedure.The physician has decided to leave the filter in place.Did any unintended section of the device remain inside the patient¿s body? yes, the filter itself remains inside the patient's body.The complainant did not report any further adverse effects to the patient due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a tulip filter was accidentally deployed with the filter feet in the right common iliac and one year later the filter was found tilted.2 weeks later a clover snare was advanced to retrieve the filter, but despite several attempts the filter feet would not get off the vena cava wall.It was decided to leave the filter in place.No adverse effects on the patient reported.No imaging of the retrieval attempt was provided.The image provided is a single image from a venogram after deployment of the gunther tulip ivc filter and demonstrates the filter feet engaged with the ostium of the right common iliac vein and the cone of the filter extending into the ivc.The filter makes approximately 13 degree angle relative to the long axis of the ivc and extends across the ostium of the left iliac vein.In this configuration, thrombus from the left lower extremity could transverse past the ivc filter as it is not filtering the blood returning from the left leg.The complaint report does not elaborate on the deployment except the comment "filter was accidentally deployed".With the information provided in this single image, it is confirmed that the filter is deployed in the right common iliac vein while the ivc and iliac venous anatomy appears completely normal.This is likely a result of physician error.Approx.One year after filter placement a clover snare was advanced to retrieve the filter, but despite several attempts the filter feet would not get off the vena cava and it was decided to leave the filter in place and no adverse effects to the patient have been reported.Based on the information provided the exact reason for the unsuccessful retrieval attempt cannot be determined.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.No evidence to suggest product was not manufactured to specifications cook medical will continue to monitor for similar events.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.

• 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: 11371323
• MDR Text Key: 234370405
• Report Number: 3002808486-2021-00151
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1