MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER

Model Number N/A

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

Patient Problems Embolus (1830); Occlusion (1984); Swelling (2091); Pseudoaneurysm (2605); No Code Available (3191)

Event Date 05/07/2015

Event Type  Injury  

Manufacturer Narrative

As reported in the legal brief, gillespie vs.Cordis, approximately 11 years after trapease filter implantation it was explanted due to ongoing pain.The patient continues to suffer pain following the removal of the device.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.The trapease 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.The events reported do not represent a device malfunction.The reported explanting of the device and pain could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.

Event Description

As reported in the legal brief, gillespie vs.Cordis, approximately 11 years after trapease filter implantation it was explanted due to ongoing pain.The patient continues to suffer pain following the removal of the device.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported, the patient underwent implantation of a trapease permanent inferior vena cava (ivc) filter for the treatment of a lower extremity deep vein thrombosis (dvt).Per the medical records, the patient has a history of factor v leiden abnormality, morbid obesity, venous insufficiency, hypertension, bilateral dvt, lymphedema, pulmonary embolism (pe) and had been pharmacologically anticoagulated.The filter was placed prophylactically prior to bariatric surgery.During the filter placement procedure, the filter was deployed in the l2-l3 interspace.The device caused the patient ongoing pain.It was deemed that this permanent filter needed to be extracted.The patient required surgical intervention to remove the filter.Ten years and ten months post implantation, the filter was removed.Per the medical records, prior to the removal the patient presented to the hospital with abdominal and groin pain, bilateral foot/lower extremity swelling, and increased prominence in veins of the lower extremities.The filter was removed using loop and laser sheath techniques.The filter was sheathed until meeting a point of resistance along the bottom third of the filter.The area could not be sheathed.The laser was then activated for tissue ablation, and capture of the filter was achieved.Aspiration thrombectomy was then performed through the sheath.A balloon venogram and retrograde balloon sweep of the ivc and right iliac vein was also performed.A post retrieval inferior vena cavagram showed a patent ivc with brisk antegrade flow.There was a very small pseudoaneurysm along the right caval wall at the level of l3 with no extravasation and a small non-occlusive acute thrombus at the level of the l3.The patient tolerated the removal procedure well and had no immediate complications.Per the patient profile form (ppf), the patient had blood clots clotting and occlusion of the ivc.The patient also reports anxiety.The filter is unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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.Filter removal is a known potential event associated with the use of the trapease filter.Although the indication for placement is as a permanent implant, patient related issues can be indications of the need to remove the filer from the ivc.Blood clots and occlusive and non-occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Pseudoaneurysm and swelling do not represent a device malfunction and may be related to underlying patient related issues.Anxiety 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.The following additional information received per the patient profile form (ppf) indicates that the patient had blood clots clotting and occlusion of the inferior vena cava (ivc).The patient also reports to be suffering from fear, mood swings, difficulty concentrating, loss of focus, depression and anxiety.Per the medical records, prior to the removal the patient presented to the hospital with abdominal and groin pain, bilateral foot/lower extremity swelling, and increased prominence in veins of the lower extremities.The filter was removed using loop and laser sheath techniques.The filter was sheathed until meeting a point of resistance along the bottom third of the filter.The area could not be sheathed despite applying 7.0 lbs of tension.The laser was then activated for tissue ablation, and capture of the filter was achieved with only 4.0 lbs of tension.Aspiration thrombectomy was then performed through the sheath.A balloon venogram and retrograde balloon sweep of the ivc and right iliac vein was also performed.A post retrieval inferior vena cavagram showed a patent ivc with brisk antegrade flow.There was a very small pseudoaneurysm along the right caval wall at the level of l3 with no extravasation and a small non occlusive acute thrombus at the level of the l3.The patient tolerated the removal procedure well and had no immediate complications.According to the information received in the medical records, the patient has a history of factor v leiden abnormality, morbid obesity, venous insufficiency, hypertension, bilateral dvt, lymphedema, pulmonary embolism (pe) and had been anticoagulated.The filter was placed prophylactically prior to bariatric surgery.During the filter placement procedure, the filter was deployed in the l2-l3 interspace.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6591582
• MDR Text Key: 76015073
• Report Number: 1016427-2017-00307
• Device Sequence Number: 1
• Product Code: DQO
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Distributor Facility Aware Date: 05/04/2017
• Date Manufacturer Received: 06/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Age: 69 YR
• Patient Weight: 137