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

Catalog Number 466F220A

Device Problem Unintended Movement (3026)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

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 a trapease 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 perforation and 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 and perforation¿ 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 event.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.¿ additionally, the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.The timing or mechanism of the tilt has not been reported at this time.It is unknown if the tilt contributed to the perforation.Without images available for review the reported tilt or perforation could not be confirmed or further clarified.Since no lot number was 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 a trapease 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 perforation and 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, b6, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt) and pulmonary embolism while on anticoagulation treatment for dvt.Prior to the procedure the patient had recent bleeding inside her left arm and coumadin toxicity.An echocardiogram revealed the patient's pulmonary artery pressure was 48 mmhg.The filter was deployed via the patient's right common femoral vein using the seldinger technique.The filter was placed without complications.A post procedural angiogram was done, it revealed that the filter was in a "beautiful location."   additional information received per the patient profile form (ppf) states that the patient experienced filter tilt and perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported events twelve years after the index procedure.The patient also reported that they continue to experience repeated stomach pain.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable cava filter.The patient is reported to have had a history of deep vein thrombosis (dvt) and pulmonary embolism despite anticoagulation therapy.The patient had recently developed bleeding inside her left arm along with coumadin toxicity.Diagnostic testing revealed a pulmonary artery pressure (pap) of 48mmhg.The indication for the filter placement was not reported.The filter was implanted via the right common femoral vein and placed in a ¿beautiful location¿.The patient is reported to have tolerated the procedure well and without complications.Approximately twelve years after the filter implantation, the patient became aware that the filter had tilted, and filter struts had perforated outside the inferior vena cava (ivc).The patient further reported having experienced recurrent stomach 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 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.Due to the nature of the complaint, the reported 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.

• 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: 12342393
• MDR Text Key: 267268030
• Report Number: 1016427-2021-05303
• 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,Followup
• Report Date: 10/14/2021

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Catalogue Number: 466F220A
• Device Lot Number: R0808438
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN 6 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR