MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE FILTER; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306X

Device Problems Failure To Adhere Or Bond (1031); Therapy Delivered to Incorrect Body Area (1508)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Event Description

During a literature review, as reported by: georgiou et al, ct of inferior vena cava filters: normal presentations and potential complications; emergency radiology (2015); 1-12.In the first case, a (b)(6) man with a history of bilateral thrombosis of the iliac veins was not a candidate for anticoagulation.An infrarenal trapease inferior vena cava (ivc) filter was attempted via a right internal jugular venous approach.Upon release, the filter did not expand to the full width of the ivc as shown on a coronal non-contrast computerized tomography (ct) thick-slab reconstruction and on axial ct.The lower two thirds of the filter was released outside of the ivc within the gonadal vein, partially expanded.A g܎ther tulip filter was then placed suprarenally immediately following placement of the original trapease ivc filter.No sequelae was noted on ct.

Manufacturer Narrative

During a literature review, as reported by: georgiou et al, ct of inferior vena cava filters: normal presentations and potential complications; emergency radiology (2015); 1-12.In the case of a (b)(6) patient, with a history of bilateral thrombosis of the iliac veins who was not a candidate for anticoagulation, placement of an infrarenal trapease inferior vena cava (ivc) filter was attempted via a right internal jugular venous approach.Upon release, the filter did not expand to the full width of the ivc as shown on a coronal non-contrast computerized tomography (ct) thick-slab reconstruction and on axial ct.The lower two thirds of the filter was released outside of the ivc within the gonadal vein, partially expanded.A gunther tulip filter was then placed suprarenally immediately following placement of the original trapease ivc filter.No sequelae was noted on ct.The author also notes that even with ¿standard¿ caval anatomy, deployment of ivc filters not in the ivc can occur.Deployment of ivc filters in the iliac veins, partially outside the ivc, or even very rarely into the spinal canal, has all been reported.The device remained implanted in the patient and was not returned for analysis.A device history record review (dhr) could not be conducted as a sterile lot number was not provided.The reported ¿filter ¿ inaccurate placement¿ and ¿filter ¿ incomplete expansion¿ was confirmed through images provided in the publication.The exact cause could not be determined.Based on the information available for review, the inaccurate placement of the filter likely let to incomplete expansion of the filter due to the vessel anatomy and position of the deployed filter.Given the information available and without a dhr, there is no indication that the product¿s design or manufacturing process contributed to this event; therefore, no corrective action will be taken at this time.

• Brand Name: TRAPEASE FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5042294
• MDR Text Key: 24617456
• Report Number: 9616099-2015-00403
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR