MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

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 and damage to the patient, including but not limited to perforation.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.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.The reported perforation could not be confirmed without procedural films for review.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues 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 by the legal brief, the 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 perforation.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.

Manufacturer Narrative

After further review of additional information received the following sections a3,b3,b5,b7,d11,g4,g7,h2 and h6 have been updated accordingly.Section b5: addendum for additional information received:the following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported events, 70 months, 30 days post implantation.The ppf notes that the filter struts perforated outside of the inferior vena cava (ivc).The patient reported to be suffering from anxiety of having a filter that could fail at any time, and that it may not be retrievable without surgery, but no known attempts has been made.The patient also states to be living in fear that the filter has perforated outside of the vena cava.According to the information received in the medical records, the patient¿s pre-operative diagnosis was deep vein thrombosis on the left popliteal vein, gastrointestinal bleeding and unable to anticoagulate.According to the medical records the patient was diagnosed with a dvt and started on lovenox.After the lovenox, the patient developed gastrointestinal (gi) bleeding, the patient was seen and treated.An ulcer was found in the stomach that was actively bleeding and they were able to control the bleeding.The indications for placing the filter is because the patient has a history of dvt and has a high risk for pulmonary embolism.The right groin was prepped and a needle trocar was introduced to the femoral vein.The filter was deployed at the level of l2.The trapease filter was adequately deployed and opened widely and straight.The patient tolerated the procedure with no problem and no complications.As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of deep vein thrombosis (dvt) of the left popliteal vein and gastrointestinal bleeding with ulcer.Anticoagulation was therefore deemed to be contraindicated.The indication for the filter placement was the patient¿s high risk for pulmonary embolism (pe).The filter was implanted via the right femoral vein and placed at the level of l2.The patient is reported to have tolerated the procedure well without complication.Approximately five years and eleven months after the implantation, the patient became aware that filter strut(s) had perforated outside of the inferior vena cava (ivc).The patient further reported having experienced anxiety and fear associated with the filter.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.The reported ivc perforation could not be confirmed without procedural films for review.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, unease and worry.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.

• Brand Name: UNKNOWN TRAPEASE FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8600412
• MDR Text Key: 144726897
• Report Number: 1016427-2019-02801
• Device Sequence Number: 1
• Product Code: DQO
• 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,other
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 73 YR