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

Catalog Number 466F220A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to 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 continue to suffer significant medical expenses, pain and suffering, and other damages.Additional information received per the medical records indicate that the patient has a history of a fall with multiple lower left lower extremity fractures, multiple pelvic fractures and bilateral femoral vein deep venous thromboses.The filter was deployed via the patient's right femoral vein using the seldinger technique.There was adequate placement with no tilt.Placement was confirmed under fluoroscopy.The patient tolerated the procedure well.¿ additional information received per the patient profile form (ppf) states that the patient experienced stenosis and caval thrombosis.The patient became aware of the reported events approximately twelve years and ten months after the index procedure.The patient also reported lightheadedness and that the filter is clogged which caused lack of blood flow, breathing difficulty and loss of stamina.

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 a fall with multiple lower extremity and pelvic fractures and bilateral femoral deep vein thrombosis (dvt).The indication for the filter placement was reported to be as prophylaxis prior to planned orthopedic surgeries.The filter was implanted via the right femoral vein.The patient is reported to have tolerated the procedure well and without complications.More than twelve years after the filter implantation, the patient became aware that the filter was associated with stenosis, device occlusion and caval thrombosis.The patient further reported having experienced lightheadedness, lack of blood flow, breathing difficulty and loss of stamina 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.Stenosis, 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 lightheadedness 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.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 60 avenue; miami lakes FL 33014
• MDR Report Key: 12373690
• MDR Text Key: 268441359
• Report Number: 1016427-2021-05343
• Device Sequence Number: 1
• Product Code: DTK
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: R1207002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR