MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306X

Device Problems Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Occlusion (1984)

Event Date 10/27/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 and occlusion.The indication for the filter implant, patient medical history and procedural details have not been provided.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 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, it is unknown if it was a stenotic or thrombotic event.Blood clots, clotting and/or occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.With the limited information provided it is not possible to draw a conclusion between the events and the device.There is nothing in the information provided to suggest that there is a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.Please note that this is the initial/final report for this product.

Event Description

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

Event Description

Additional information received per the medical records indicate that the patient has a history of pulmonary thromboembolic disease and cardiac failure.  the admitting diagnosis was bilateral multifocal pulmonary embolism with fa.The filter was deployed via the patient's right common femoral vein using ultrasound for guidance.It was placed into the infrarenal location within the inferior vena cava.The patient tolerated the procedure well without evidence of immediate complication.Additional information received per the patient profile form (ppf) states that the patient experienced tilting of the filter, blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).The patient continues to experience worry and anxiety.The patient became aware of the reported events two years and six months after the index procedure.

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 and occlusion.The patient reported becoming aware of filter tilt, blood clots, clotting and/or occlusion of the inferior vena cava (ivc) approximately two years and six months post implant.The patient has also reported worry and anxiety.According to the implant record the indication for the filter implant was bilateral pulmonary thromboembolic disease with cardiac failure.The filter was placed via the right common femoral vein and deployed in the infrarenal ivc after confirming no evidence of caval thrombus by venacavogram.The patient tolerated the procedure well with no immediate complications.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 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, it is unknown if it was a stenotic or thrombotic event.Blood clots, clotting and/or occlusive thrombosis within the filter and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without images or procedural films for review, the reported filter tilt could not be confirmed, and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.With the limited information provided it is not possible to draw a conclusion between the events and the device.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.There is nothing in the information provided to suggest that there is a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33152
• MDR Report Key: 9914338
• MDR Text Key: 188517674
• Report Number: 1016427-2020-03982
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/20/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDE WIRE; UNKNOWN INTRODUCER CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR