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

Catalog Number IGTCFS-65-1-JUG-TULIP

Device Problems Leak/Splash (1354); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) investigation is still in progress.

Event Description

Description of event according to complainant: upon initial deployment of the tulip filter (jugular), the primary struts did not appear to expand all the way and gain wall apposition.The filter was retrieved and upon the post removal cavagram, there appeared to be some possible extravasation.An angioplasty balloon then was placed in the ivc and inflated to stop the possible extravasation.A second tulip filter (jugular) was then successfully deployed.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Summary of investigation findings: based on a review of the provided imaging in all likelihood the filter was inadvertently deployed with the feet engaging the ostium of the large vertebral vein inhibiting the filter from deploying appropriately in ivc.Following filter retrieval likely lacerated the vertebral vein ostium.Investigation found no evidence to suggest the product was not manufactured according to specifications and there is no reason to believe the problem was inherent in the filter.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: upon initial deployment of the tulip filter (jugular), the primary struts did not appear to expand all the way and gain wall apposition.The filter was retrieved and upon the post removal cavagram, there appeared to be some possible extravasation.An angioplasty balloon then was placed in the ivc and inflated to stop the possible extravasation.A second tulip filter (jugular) was then successfully deployed.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5305615
• MDR Text Key: 34584620
• Report Number: 3002808486-2015-00191
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2013
• 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): Other