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

Catalog Number 466F220A

Device Problem Unintended Movement (3026)

Patient Problems Stroke/CVA (1770); Pain (1994); Unspecified Tissue Injury (4559)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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, filter tilt.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, and pain and suffering, loss of enjoyment of life and other damages.The device was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿filter-tilt¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Procedural/handling factors, or vessel characteristics, although unknown, may have contributed to the reported events.According to the ifu, which is not intended as a mitigation of risk, ¿possible long-term complications associated with filter implantation include, but are not limited to, the following: filter obstruction, filter perforation of the vena cava wall, filter migration, filter fracture, recurrent pulmonary embolism.¿ ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Without images available for review, the reported tilt could not be confirmed or further clarified.The timing and mechanism of the tilt has not been reported at this time.Due to no lot number being provided, a phr could not be generated.The limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.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 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 filter tilt.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, and pain and suffering, loss of enjoyment of life and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient presented with multiple pulmonary emboli (pe).The indication for the filter placement was not reported.The filter was implanted via the right common femoral vein and placed at the level of l3 without incident.Approximately six years and nine months after the filter implantation, the patient became aware that the filter had tilted.The patient further reported having experienced a stroke and right leg pain 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 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 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.Due to the nature of the complaint, the reported stroke 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.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.

Event Description

Additional information received per the medical records indicate that the patient has a history of multiple pulmonary emboli (pe).Initially the right common femoral artery was inadvertently punctured.Direct pressure was held on the site for hemostasis.Ultrasound was used to delineate the right common femoral vein.The vein was punctured without incident.The filter was deployed at the l3 level.The filter was in an excellent position.  additional information received per the patient profile form (ppf) states that the patient experienced filter tilt.The patient became aware of the reported event approximately six years and nine months after the index procedure.The patient also reported that they experienced a stroke and right leg pain related to the filter.

• 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: 12341993
• MDR Text Key: 267294656
• Report Number: 1016427-2021-05300
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 466F220A
• Device Lot Number: 15182402
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.018 GUIDEWIRE; UNKNOWN 035 J-TIPPED GUIDEWIRE; UNKNOWN 6-FRENCH CATHETER; UNKNOWN 6-FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR