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

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Occupation: non-healthcare professional, purchaser.Pma/510(k): k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the feet of the filter are in the right common iliac.The filter was accidentally deployed that way on (b)(6) 2020.They are intending to retrieve the filter.The anatomical location of the filter deployment was top in the distal ivc with the feet landing in the right proximal common iliac.The orientation and tilt of the filter at implant is originally unknown but it is presently tilted.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects 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.After an unsuccessful retrieval attempt 2 weeks after noted tilt (handled in complaint (b)(4) ref£3002808486-2021-00151) it was decided to leave the filter in place.No adverse effects on the patient reported.Single image from a venogram after deployment of a gunther tulip ivc filter 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.After an unsuccessful retrieval attempt approx.One year after the placement, it was decided to leave the filter in place.No adverse effects to the patient have been reported.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: 11336848
• MDR Text Key: 232323350
• Report Number: 3002808486-2021-00127
• 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

• 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
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention