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

Catalog Number IGTCFS-65-8.5-1-FEM-TULIP

Device Problems Fracture (1260); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) catalog # is igtcfs-65-8.5-1-fem-tulip.Lot# is unknown as information was not provided.Expiration date unknown as lot# is unknown.Pma/510(k): k112119.Investigation is still in progress.

Event Description

Description according to complainant: a patient had gone for another procedure, when the physician noted that the filter had fractured.The physician went in to retrieve the filter and was able to remove most of the device except for the parts that had fractured.One leg was not found and the physician believed it was passed naturally.Patient outcome: the patient post procedure was doing well.No further procedures or intervention is being scheduled.

Manufacturer Narrative

(b)(4).Catalog # is igtcfs-65-8.5-1-fem-tulip.Lot# is unknown as information was not provided.Expiration date unknown as lot# is unknown.Pma/510(k): k112119.Summary of investigation: the filter was severely damaged and two primary legs had fractured.Patient's medical records are unknown, and so is filter implant period, but based on the amount of tissue on the two intact primary legs, a strong/long term ingrowth is assumed.The secondary legs attached to the two fractured primary legs have fractured, too, and approx.Half of them is missing.On one of the intact primary legs half of the secondary legs has fractured, but the other half is intact.The secondary leg on the second intact primary leg is deformed, but intact.Every fracture is found related to stress/fatigue.Based on investigation findings and information provided, the filter had fractured during unknown implant period.It is cook¿s experience that fracture of filter legs is due to unidirectional bending fatigue.The type of fatigue is a high cycle fatigue where cyclic low stresses with low stress concentrations were applied to the filter leg.The bending moment of the filter leg may be introduced by different scenarios that in some instances will change the filter¿s original configuration, e.G.By perforation of the ivc wall or; by caught in a body structure (e.G.Renal vein).Lot # is unknown, but there is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.

Event Description

Description according to complainant: a patient had gone for another procedure, when the physician noted that the filter had fractured.The physician went in to retrieve the filter and was able to remove most of the device except for the parts that had fractured.One leg was not found and the physician believed it was passed naturally.Patient outcome: the patient post procedure was doing well.No further procedures or intervention is being scheduled.

• Brand Name: NAVALIGN GUNTHER TULIP FEMORAL 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: 5297012
• MDR Text Key: 34252750
• Report Number: 3002808486-2015-00179
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-8.5-1-FEM-TULIP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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