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

Model Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problem Perforation of Vessels (2135)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The report indicated that the filter subsequently malfunctioned and caused tilting and perforation of multiple filter struts outside the wall of the inferior vena cava (ivc).The indication for the filter placement, procedural details and medical history have not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The optease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to 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

As reported in 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, tilting and perforation of multiple filter struts outside the wall of the inferior vena cava (ivc).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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, a5, b1, b3, b4, b5, b6, b7, d1, d4, d11, g3, g4, g7, h1, h2, h4 and h6.It was reported that a patient underwent placement of an optease vena cava filter.The report indicated that the filter subsequently malfunctioned and caused tilting and perforation of multiple filter struts outside the wall of the inferior vena cava (ivc).The patient reported becoming aware of tilting and perforation, as indicated by a computed tomography (ct) scan, approximately eight years post implant.The patient also reported experiencing pain post implant and anxiety related to the filter.According to the implant record the indication for the filter placement was left lower extremity deep vein thrombosis with a contraindication to anticoagulation.The record noted that the patient was postpartum and had developed an intracranial hemorrhage and subsequent left hemiparesis.The patient had gone to a rehabilitation facility and developed the dvt, the patient was brought in for anticoagulation but then developed significant anemia, as such the filter was placed for protection of pulmonary emboli.The filter was placed via access of the right common femoral vein.Venacavogam performed prior to the filter placement noted significant encroachment on the left iliac vein with what appeared to be thrombus, the channel for the right iliac vein was small, but patent.The filter was deployed in the ivc below the renal veins.The patient tolerated the procedure well with no obvious complications.There is currently no additional information available for review.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 vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava 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.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.It is unknown if the tilt contributed to the reported perforation.Due to the nature of the complaint the post implant pain reported by the patient could not be further clarified.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to 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 deep vein thrombosis in the left leg with contraindication to anticoagulation therapy, anemia, postpartum and subsequently developed an intracranial hemorrhage and subsequently left hemiparesis.The filter was placed for protection from pulmonary emboli.  the filter was deployed via ultrasound guidance through the patient's right common femoral vein.There was significant encroachment on the left common iliac vein with what appeared to be thrombus.There was very small channel for the right common iliac vein, but it was patent.The filter was placed below the renal veins.It was laid in quite nicely and straight.The patient tolerated the procedure well.There were no obvious complications.A post-procedural computed tomography (ct) scan reported tilt and perforation of multiple filter struts outside the wall of the inferior vena cava (ivc).The patient further asserts to have suffered from pain post implant as a result of the filter.Additional information received per the patient profile form (ppf) states that the patient experienced tilting, perforation of filter struts outside the wall of the inferior vena cava (ivc) and pain.These events have caused emotional distress, mental anguish, anxiety and stress.The patient became aware of the reported events eight years after the index procedure.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 10152543
• MDR Text Key: 195268531
• Report Number: 1016427-2020-04011
• 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: 08/12/2020

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: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: R1007279
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 18-GAUGE NEEDLE; UNKNOWN 6-FRENCH SHEATH; UNKNOWN J-WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 30 YR