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

Catalog Number 466P306X

Device Problem Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2022

Event Type  Death  

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.(b)(4).It was reported that a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused filter tilted anteriorly at the superior end and laterally at the interior end with all struts perforating the inferior vena cava (ivc) up to 5mm.Two anterior struts perforate the ivc 3 mm and 5 mm.One medal strut perforates the ivc wall by 5 mm and two posterior struts perforate the ivc wall by 5 mm, with all residing within the soft tissues.It was noted that the patient is deceased, however a relationship between the event and the filter was not provided.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.Ivc filter tilt has been associated with practitioner technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.It was noted in the information provided that the patient is deceased, with the limited information provided and no cause of death reported a clinical determination or relationship to the filter could not be established.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.Please note that this is the initial 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 filter tilted anteriorly at the superior end and laterally at the interior end with all struts perforating the inferior vena cava (ivc) up to 5mm.Two anterior struts perforate the ivc 3 mm and 5 mm.One medal strut perforates the ivc wall by 5 mm and two posterior struts perforate the ivc wall by 5 mm, with all residing within the soft tissues.The patient is deceased, but there was no information provided to relate their demise to the device.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

• Brand Name: UNKNOWN TRAPEASE
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15324241
• MDR Text Key: 298946427
• Report Number: 9616099-2022-05931
• Device Sequence Number: 1
• Product Code: DTK
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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
• Date Manufacturer Received: 08/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female