MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Difficult to Remove (1528)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Occlusion (1984); Perforation of Vessels (2135)

Event Date 12/08/2003

Event Type  Injury  

Manufacturer Narrative

The catalog number and lot number are unknown; if received it will be provided.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: the patient suffered thrombosis below filter and possible perforation.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.According to the information on the patient profile form the patient experienced blood clots/clotting and/or occlusion of the inferior vena cava (ivc) and the device was unable to be retrieved.The patient became aware of the issue approximately 47 days post implant, when an unsuccessful percutaneous attempt to retrieve the filter was made.The patient also reports experiencing a pulmonary embolism, deep vein thrombosis and mental anguish related to the filter.According to the medical records, the indication for the filter implant was clinically significant pulmonary embolism (pe) despite being on anticoagulation for a deep vein thrombosis (dvt) following significant trauma to the lower extremities.The filter was placed via the right common femoral vein and deployed within the infrarenal inferior vena cava (ivc).Approximately forty-seven days post implant, the patient presented for an ivc gram to evaluate the filter for removal.An ivc venogram was performed and demonstrated apparent incorporation of the filter into the cava sidewall and therefore retrieval was not performed.Approximately 12 years and seven months post implantation, the patient underwent an x-ray of the lumbar spine for worsening chronic low back pain.Results showed minimal chronic degenerative disc disease in the l1-l2 and l2-l3 levels.And mild chronic degenerative disc disease at t11-12.The ivc filter was observed and a small metallic wire-like component of the ivc filter was noted to be deviated medially towards the anatomic midline.An abdominal x-ray was also performed for constipation and abdominal pain, no free air was noted.

Manufacturer Narrative

Complaint conclusion: as reported, the patient had placement of an optease inferior vena cava (ivc) filter.Per the medical records, the indication was pulmonary embolism (pe) while on anticoagulation for a deep vein thrombosis (dvt) following significant trauma to the lower extremities.The filter was deployed within the ivc.The filter subsequently malfunctioned and caused injury and damages including, but not limited to thrombosis below the filter and possible perforation.Per the patient profile form (ppf), the patient reports blood clots/clotting and/or occlusion of the inferior vena cava (ivc) and an unsuccessful percutaneous retrieval attempt.The patient also reports a pulmonary embolism, deep vein thrombosis and mental anguish.Approximately forty-seven days post implant, the patient presented to evaluate the filter for removal.An ivc venogram was performed and demonstrated apparent incorporation of the filter into the ivc sidewall and therefore retrieval was not performed.Approximately 12 years and seven months post implantation, the patient underwent an x-ray of the lumbar spine for worsening chronic low back pain.Results showed minimal chronic degenerative disc disease in the l1-l2 and l2-l3 levels.And mild chronic degenerative disc disease at t11-12.The ivc filter was observed and a small metallic wire-like component of the ivc filter was noted to be deviated medially towards the anatomic midline.An abdominal x-ray was also performed for constipation and abdominal pain, no free air was noted.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 optease 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.Without procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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 12 days.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Ivc perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Post procedural pulmonary embolism is a known potential event associated with the filter device, patent specific issues, specifically the underlying causes of thrombus formation, may contribute to these events.Anxiety does 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.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9535167
• MDR Text Key: 173199339
• Report Number: 1016427-2019-03711
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Life Threatening
• Patient Age: 24 YR