MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306AU

Device Problem Insufficient Information (3190)

Patient Problems Coagulation Disorder (1779); Obstruction/Occlusion (2422)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused occlusion.The indication for the filter implant has not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.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.Occlusion was reported, however with the limited information provided the event could not be further clarified.Blood clots, clotting, and occlusion of the device or vasculature does not indicate a device malfunction.With the limited information provided a clinical conclusion could not be made, however, patient, vessel characteristics and pharmacological factors may have contributed to these events.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported in the legal brief, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to occlusion.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused occlusion.The patient reported becoming aware of blood clots, clotting and occlusion of the inferior vena cava (ivc), approximately three years and nine months post implant.The patient also reported anxiety related to the filter.According to the implant record the patient had a history of obesity, cerebrovascular accident (cva), deep vein thrombosis (dvt), hypertension, anemia, hypercoagulable state, and was not considered a candidate for anticoagulation.The patient underwent successful ivc filter placement and deployment below the renal veins followed by angiojet thrombectomy of the ivc.The product remains implanted and unavailable for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The trapease ivc filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.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.Occlusion was reported, however with the limited information provided the event could not be further clarified.Blood clots, clotting, and occlusion of the device or vasculature does not indicate a device malfunction.With the limited information provided a clinical conclusion could not be made, however, patient, vessel characteristics and pharmacological factors may have contributed to these events.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues or comorbidities.There is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

Per the implant records, the patient was reported to have a history of obesity, cerebrovascular accident (cva), deep vein thrombosis (dvt), hypertension, anemia, hypercoagulable state, and was not considered a candidate for anticoagulation.The patient underwent successful inferior vena cava (ivc) filter placement and deployment below the renal veins followed by angiojet thrombectomy of the ivc.According to the information received in the patient profile form (ppf), the patient reports blood clots, clotting and occlusion of the ivc, becoming aware of these events approximately three years and nine months after the filter implantation and further experienced anxiety related to the filter.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 11705794
• MDR Text Key: 246689834
• Report Number: 1016427-2021-04923
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15539685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2012
• 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): Life Threatening
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Race: Black Or African American