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

Catalog Number 466P306X

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

Patient Problem Embolus (1830)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Date of event: please note that the exact event date is unknown and the event date is the complaint awareness date.Description of problem or event: as reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to severe persistent chest pain, pain throughout his body, shortness of breath, headache, difficulty walking, and several blood clots have passed through the filter.The filter remains implanted; thus, unavailable for analysis.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 vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.Blood clots in the vasculature do not represent a device malfunction.The trapease was designed to impede large volume blood cots from flowing into the central venous system.Due to the nature of the open space design, intended to allow blood flow through the vasculature, small caliber clots will pass through the struts of the filter.Shortness of breath, headache, difficulty walking, and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to 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: severe persistent chest pain, pain throughout his body, shortness of breath, headache, difficulty walking and several blood clots have passed through the filter.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: additional information received per the medical records indicate that the patient has a history of deep vein thrombosis.The filter was deployed via the patient's right common femoral vein.It was placed with the apex at the superior aspect of l2.The filter was in good alignment.The patient tolerated the procedure well without any complications.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes deep vein thrombosis.The filter was deployed with the apex at the superior aspect of l2.The filter was in good alignment.The patient tolerated the procedure well without any complications.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to severe persistent chest pain, pain throughout his body, shortness of breath, headache, difficulty walking, and several blood clots have passed through the filter.Per the patient profile form (ppf), the patient reports continuous discomfort and mental anguish.The form reports both an unsuccessful removal which left the device in place and that there has been no attempt to remove the device.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.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported shortness of breath, headache, walking difficulty and pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events 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, mental anguish, fear, 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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b4, g4, g7, h1 and h2.Section b5: additional information received per the patient profile form (ppf) states that the patient experienced continuous discomfort and mental anguish.The form states there was an unsuccessful removal which left the device in place; however, the form also states that there has been no attempt to remove the device.As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the filter is reported to have been associated with several blood clots.The patient reported having undergone an unsuccessful attempt to remove the device; though attempts to retrieve it were unsuccessful.The patient further reported having experienced continuous discomfort, mental anguish, severe persistent chest pain, pain throughout the body, shortness of breath, headache and difficulty walking 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.Blood clots and thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported shortness of breath, headache, walking difficulty and pain experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events 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, mental anguish, fear, 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 VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8871329
• MDR Text Key: 153971839
• Report Number: 1016427-2019-03138
• 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,Followup
• Report Date: 11/07/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 09/19/2019; 10/10/2019
• Supplement Dates FDA Received: 10/16/2019; 11/07/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 GUIDE WIRE; UNKNOWN 5-FRENCH TENNIS RACQUET CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR