MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220A

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Emotional Changes (1831); Pain (1994); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to perforation, tilting, clot in the filter, stenosis and caval thrombosis.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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a preoperative diagnosis of severe obesity.The right groin was prepped and draped into a sterile field.The right common femoral artery and the vein medical to this, was identified using doppler and the vein was cannulated using seldinger technique.A guidewire, dilator and introducer were sequentially advanced over the guidewire to the proximal right common iliac vein.A venogram was performed followed by an inferior vena cavagram and the diameter of the inferior vena cava at the point of deployment of the filter was measured.The filter was deployed in the distal inferior vena cava.The patient tolerated the procedure well.

Event Description

As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to perforation, tilting, clot in the filter, stenosis and caval thrombosis.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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a preoperative diagnosis of severe obesity.The right groin was prepped and draped into a sterile field.The right common femoral artery and the vein medical to this, was identified using doppler and the vein was cannulated using seldinger technique.A guidewire, dilator and introducer were sequentially advanced over the guidewire to the proximal right common iliac vein.A venogram was performed followed by an inferior vena cavagram and the diameter of the inferior vena cava at the point of deployment of the filter was measured.The filter was deployed in the distal inferior vena cava.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the inferior vena cava (ivc), tilting, blood clots, clotting, occlusion of the ivc and stenosis, becoming aware of these events approximately twelve years and eleven months after the filter implantation, and further experienced anxiety and depression related to the filter.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of severe obesity.The indication for the filter placement was not reported.The filter was implanted via the right common femoral vein and placed in the distal inferior vena cava (ivc).The patient is reported to have tolerated the procedure well.At some point after the filter implantation, the patient became aware that the filter had tilted and was associated with stenosis, filter and caval thrombosis, perforation of the ivc, blood clots, clotting and/or occlusion of the ivc.The patient further reported having experienced anxiety and depression associated with the filter.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The optease retrievable 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 images or procedural films for review, the reported filter tilt and ivc perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological 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: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 12238782
• MDR Text Key: 264037956
• Report Number: 1016427-2021-05146
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1107244
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK DILATOR AND INTRODUCER; UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR