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

Model Number 466F220A

Device Problem Unintended Movement (3026)

Patient Problem Perforation of Vessels (2135)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.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 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, pain and suffering, and other damages.Additional information received per the medical records indicate that the patient had a recent history of multitrauma after a motorcycle accident.The filter was deployed via the patient's right groin.The filter was inserted in position just inferior to the renal veins at the level of the inferior portion of the l2.Immediately after placement of the filter attention was turned to performing a skin graft on the patient's right leg.The patient tolerated the procedures very well.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava and tilt.The patient became aware of the reported events approximately seventeen years and seven months after the index procedure.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have been involved in a recent multi-trauma motorcycle accident.The indication for the filter placement was not reported; but is presumed to be as prophylaxis prior to skin grafting surgery for the patient¿s right lower extremity.The filter was implanted via the right groin and placed in an infrarenal position.The patient is reported to have tolerated the procedure well.More than seventeen years after the filter implantation, the patient became aware that the filter tilted and that filter struts had perforated outside the inferior vena cava (ivc).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 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.Clinical factors that may have influenced the event 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: 12362823
• MDR Text Key: 267989914
• Report Number: 1016427-2021-05335
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2005
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1002046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER.; UNKNOWN SHEATH.; UNKNOWN CATHETER; UNKNOWN SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR