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

Model Number 466FXXXX

Device Problem Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation (2001); Great Vessel Perforation (2152); Stenosis (2263)

Event Date 11/08/2020

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: it was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused: there is specific evidence that the filter is tilted with the apex against the ivc wall, 4mm aortic, 4mm mesenteric and 4mm vertebral perforation and ivc stenosis.The indication for the filter implant, procedural details and medical history of the patient 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 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.Stenosis is an abnormal narrowing of a vessel and does not represent a device malfunction.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and stenosis could not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with operator technique, vessel characteristics, 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.Given the limited information currently available for review, 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 by the legal brief, the patient underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: there is specific evidence that the filter is tilted with the apex against the ivc wall, 4mm aortic, 4mm mesenteric and 4mm vertebral perforation and ivc stenosis.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused: there is specific evidence that the filter is tilted with the apex against the ivc wall, 4mm aortic, 4mm mesenteric and 4mm vertebral perforation and inferior vena cava (ivc) stenosis.The patient reported becoming aware of perforation of filter struts outside the ivc and tilt approximately four years and eleven months post implant.The patient also reported chest pain from filter tilt.According to the medical record the patient has a history of morbid obesity, sleep apnea, dyslipidemia, hypertension, anemia, osteoarthritis, bilateral hip replacements, transaminitis, chronic back pain, prior lumbar surgery, lumbar spine degenerative joint disease and stenosis.The indication for the filter implant was deep vein thrombosis (dvt) with a contraindication to anticoagulation, status post lumbar fusion of l3-l4 and l4-l5.It was noted that there was concern for possible infection at the operative site and may need further surgery.An exam revealed an acute appearing deep vein thrombosis of the left femoral vein extending from the proximal to the distal femoral vein.The filter was placed via the right common femoral vein and was deployed at the level of the l2-l3 intervertebral disk.A culture of the surgical wound was positive for pseudomonas aeruginosa.Approximately three weeks post implant a venous duplex ultrasound (u/s) was performed for dvt follow up, results noted progressive acute dvt in the left lower extremity (lle), more thrombus is seen proximally and distally from the common femoral vein and posterior tibial vein levels.One month later a repeat u/s, for swelling and pain, showed extensive bilateral dvt of the common femoral, superficial femoral and popliteal veins.The product remains implanted and thus not available 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.Stenosis is an abnormal narrowing of a vessel and does not represent a device malfunction.Ivc filter tilt has been associated with operator technique, vessel characteristics, 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.Without images available for review the reported events could not be confirmed or further clarified.Pain does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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 morbid obesity, sleep apnea, dyslipidemia, hypertension, anemia, osteoarthritis, bilateral hip replacements, transaminitis, chronic back pain, prior lumbar surgery, lumbar spine degenerative joint disease and stenosis.An exam revealed an acute appearing deep vein thrombosis of the left femoral vein extending from the proximal to the distal femoral vein.The indication for the filter implant was deep vein thrombosis (dvt) with a contraindication to anticoagulation, status post lumbar fusion of l3-l4 and l4-l5.It was noted that there was concern for possible infection at the operative site and may need further surgery.The filter was placed via the right common femoral vein and was deployed at the level of the l2-l3 intervertebral disk.A culture of the surgical wound was positive for pseudomonas aeruginosa.Approximately three weeks post implant a venous duplex ultrasound (u/s) was performed for dvt follow up, results noted progressive acute dvt in the left lower extremity (lle), more thrombus is seen proximally and distally from the common femoral vein and posterior tibial vein levels.One month later a repeat u/s, for swelling and pain, showed extensive bilateral dvt of the common femoral, superficial femoral and popliteal veins.Additional information received per the patient profile form (ppf) states that the patient became aware of perforation of filter struts outside the inferior vena cava (ivc) and tilt approximately four years and eleven months post implant.The patient also reported chest pain from filter tilt.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12244130
• MDR Text Key: 264051118
• Report Number: 1016427-2021-05154
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 120 KG