MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PERMANENT VENA CAVA FILTER 55CM; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306AU

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 15973976 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported by the patient through the medical affairs department, the patient had a 55 cm.Trapease pvcf fem/jug csi inferior vena cava filter implanted during the index procedure due to deep vein thrombosis.The patient reported that "x-rays show by naval on the right side." a little over a week after implantation, the patient reported experiencing "no energy, numbness, nausea" and went to the emergency room (er).It was reported that both legs and the filter had "clogged up" which was reported to have been confirmed on x-ray and magnetic resonance imaging (mri).The patient reported that he was administered four doses of tsp/clot buster drug.Multiple attempts to obtain additional information have been unsuccessful.

Manufacturer Narrative

As reported by the patient through the medical affairs department, the patient had a 55 cm.Trapease pvcf fem/jug csi inferior vena cava filter implanted during the index procedure due to deep vein thrombosis.The patient reported that "x-rays show by naval on the right side".A little over a week after implantation, the patient reported experiencing "no energy, numbness, nausea" and went to the emergency room (er).It was reported that both legs and the filter had ¿clogged up¿ which was reported to have been confirmed on x-ray and magnetic resonance imaging (mri).The patient reported that he was administered four doses of tsp/clot buster drug.Multiple attempts to obtain additional information have been unsuccessful.The product was not returned for inspection.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 15973976 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Based on the information provided and the inability to assign or determine a root cause, no corrective actions will be taken at this time.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Thrombus in the filter does not represent a device malfunction.Thrombosis in the filter is a well-known potential complication and occurs in approximately (b)(6) of all patients¿.Factors that may have influenced the event include patient, pharmacological and lesion.Without the return of the actual complaint product the event reported by the customer cannot be confirmed, nor can any conclusion regarding root cause be drawn.Based on the available information there is no evidence to suggest that the event was design or manufacturing related therefore no corrective action will be taken.

• Brand Name: TRAPEASE PERMANENT VENA CAVA FILTER 55CM
• 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: 5004874
• MDR Text Key: 23088637
• Report Number: 9616099-2015-00371
• 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: company representative,consum
• Reporter Occupation: Other
• Report Date: 07/22/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15973976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR