MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRAPEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Distress (2329); Injury (2348); No Code Available (3191)

Event Date 12/06/2019

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.As reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to fracture bending of multiple filter struts and tilt of the filter.The filter remains implanted; thus, unavailable for analysis.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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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 procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.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 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 fracture bending of multiple filter struts and tilt of the filter.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, suffering, distress and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b5, b6, b7, d11, g3, g4, g7, h1, h2 and h6.As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of anemia, knee replacement surgery and subsequent pulmonary embolism (pe).In addition, the patient was noted to be at risk for the use of anticoagulation therapy.The filter was implanted via the right common femoral vein and placed in an infrarenal position.The patient is reported to have tolerated the procedure well and without complications.Approximately nine years and five months after the filter implantation, the patient underwent a computerized tomography (ct) scan that the filter remained below the level of the renal veins.The filter was tilted anteriorly by 19-degrees.One of the posterior vertical struts appeared bent inwardly and proximally, with the struts broken and angulated posteriorly and superiorly, tangential to the right lateral margin of the aorta.In addition, the patient reported that the filter was associated with perforation of the inferior vena cava (ivc) with struts into organs.The patient reported have experienced lower body pain, constant back pain, lower stomach pain, bleeding, mental anguish and depression.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pevia 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, fracture and ivc and organ 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.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It is unknown if the tilt contributed to the reported perforations.A review of the 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 and bleeding 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.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.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 anemia and knee replacement with a subsequent diagnosis of pulmonary embolism.The filter was deployed via the patient's right common femoral vein.The filter was successfully implanted and was in an excellent position between the renal veins and iliac bifurcation.The patient tolerated the procedure well and there were no apparent complications.The results of computed tomography (ct) scans done approximately nine years and five months after the index procedure indicate that the filter is positioned below the level of the renal veins."proximally, the filter is tilted anteriorly by 19 degrees.One of the posterior vertical struts appears bent inward and proximally, with the struts broken and angulated posteriorly and superiorly, tangential to the right lateral margin of the aorta." additional information received per the patient profile form (ppf) states that the patient experienced filter fracture, filter tilt, inferior vena cava (ivc) perforation and perforation of filter struts into organs.The patient continues to experience lower body pain, constant back pain, lower stomach pain, bleeding and depression.Due to the pain and bleeding the patient is unable to have intercourse with her spouse.The patient became aware of the reported events nine years and five months after the index procedure.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10165081
• MDR Text Key: 195994897
• Report Number: 1016427-2020-04033
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 J WIRE; UNKNOWN 4 FRENCH MICROPUNCTURE KIT; UNKNOWN 4 FRENCH SHEATH; UNKNOWN 6 FRENCH BRIGHT TIP SHEATH; UNKNOWN INTRODUCER
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR