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

Catalog Number 466FXXXX

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Distress (2329)

Event Date 11/07/2017

Event Type  Injury  

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 tilting of the filter.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.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt 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.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 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 physical and emotional damages from tilting of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress 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 tilting of the filter.Filter tilt was also reported by the patient.Medical records were submitted for review, the contents of the record included documentation of outpatient office visits for routine follow up care and screening and establishing care with new facility.The patient's medical history is notable for peripheral vascular disease, type 2 diabetes mellitus, hilar adenopathy, hyperlipidemia, tobacco use, chronic obstructive pulmonary disease, gastroesophageal reflux disorder, spinal stenosis, history of venous thrombosis and embolism, chronic low back pain, carpal tunnel syndrome, hypertension, occlusion and stenosis of carotid artery with cerebral infarction, amaurosis fugax and obesity.The patient's surgical history includes appendectomy, filter for deep vein thrombosis (dvt), neck surgery and placement of a cardiac stent.Approximately ten years and ten months after the filter was implanted, the patient requested back decompression therapy after experiencing low back pain for over thirty years and starting with numbness in both legs.The indication for the filter implant and procedural details 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.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt 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.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 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 physical and emotional damages from tilting of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, loss of enjoyment of life, distress and other damages.Medical records provided for review comprised of outpatient office visits for routine follow up care and screening and establishing care with new facility.The patient's medical history is notable for peripheral vascular disease, type 2 diabetes mellitus, hilar adenopathy, hyperlipidemia, tobacco use, chronic obstructive pulmonary disease, gastroesophageal reflux disorder, spinal stenosis, history of venous thrombosis and embolism, chronic low back pain, carpal tunnel syndrome, hypertension, occlusion and stenosis of carotid artery with cerebral infarction, amaurosis fugax and obesity.The patient's surgical history includes appendectomy, filter for deep vein thrombosis (dvt), neck surgery and placement of a cardiac stent.About ten years and ten months after the filter was implanted, the patient requested back decompression therapy after experiencing low back pain for over thirty years and starting with numbness in both legs.According to the information received in the patient profile form (ppf), the patient reports tilting of the filter.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 11489785
• MDR Text Key: 239979522
• Report Number: 1016427-2021-04808
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening