MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G52916

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Great Vessel Perforation (2152)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).(b)(4).Pma/510(k): k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the filter was deployed but tilted upon deployment and perforated the caval wall.The filter was retrieved.Patient outcome: patient outcome good.The patient did not experience any pain or symptoms that could have been related to this event.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the filter was deployed but tilted upon deployment and then perforated the caval wall.The filter was retrieved with a gtrs.The patient did not experience any pain or symptoms due to this occurrence.A single image from a venogram, with imaging date (b)(6) 2020, was provided and reviewed.The image illustrates a gunther tulip filter in the infra renal ivc.Curvature of the ivc was observed.The filter was observed to be tilted, and a primary filter leg was extended outside of the column of contrast, indicating penetration.The hook of the filter appeared to abut ivc wall.Furthermore, a tulip filter and parts of a gtrs set, including a loop system catheter, a pin vise, two non-cook stop cocks and a retrieval catheter was returned and evaluated in the complaint investigation.The retrieval system was kinked, and dents were observed at the tip of the retrieval catheter.The filter was inside the retrieval catheter and was easy to deploy.No nonconformance was found on the filter.Measurements of the anchors at the primary legs, the primary legs diameter, the secondary legs high, the eyes wide and the leaf wide were all in accordance to specifications.It is unknown how the implant procedure went prior to filter deployment, and if any difficulties occurred during the procedure that could have let to filter tilt.Additionally, it is possible that deployment of the filter in a curved segment of the ivc resulted in the filter tilting and then penetrating the ivc wall.The device history record was reviewed with no evidence to suggest that the device was not manufactured according 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.

Event Description

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

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9731367
• MDR Text Key: 183137077
• Report Number: 3002808486-2020-00225
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529165
• UDI-Public: (01)10827002529165(17)220129(10)E3818790
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: G52916
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3818790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention