MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE PERMANENT VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Scarring (2061)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Please note that device reported is atrapease vena cava filter and for which the catalog and lot numbers are not currently available.Patient demographics including medical history were not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.The filter subsequently malfunctioned and caused injury, damage, including scarring and a failed retrieval.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 vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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.Without procedural films for review, the reported retrieval difficulty could not be confirmed and the exact cause could not be determined.The reported details indicate that retrieval was attempted approximately five years and five months after implantation.The trapease vena cava filter is designed for permanent implantation.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as twelve days.The patient is reported to have experienced presumed vascular scarring.Scarring is the formation of excess fibrous connective tissue in a reparative or reactive process.This can be a reactive, benign, or pathological state.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review, there is nothing to suggest that 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.

Event Description

As reported in the legal brief, the patient was treated with a trapease vena cava filter which subsequently malfunctioned and caused injury, damage, including scarring and a failed retrieval.

• Brand Name: UNKNOWN TRAPEASE PERMANENT VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8531731
• MDR Text Key: 142497822
• Report Number: 1016427-2019-02738
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• 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): Hospitalization; Life Threatening; Required Intervention