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

Model Number 466F220A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

Occupation: other, senior counsel, litigation.Date of event: please note that the exact event date is unknown and the event date is the complaint awareness date.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 perforation.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 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.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 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 event could not be confirmed or further clarified.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 report for this product.

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 perforation.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.

Event Description

Additional information received per the medical records indicate that the patient has a history of spinal deformity, due to the spine deformity the venous system in the pelvis is tortuous, a harrington rod is in place, dislocated left hip, periprosthetic fracture, left acetabulum with failed revision of hip replacement, neurofibromatosis, pulmonary embolism, secondary deep vein thrombosis and left leg thrombus.The right common iliac vein makes a sharp angle into the confluence to the inferior vena cava (ivc).The left common iliac vein appeared somewhat dilated.The ivc was small, measuring 18-20 mm in its greatest dimension.The renal veins were at the expected level.The patient was scheduled for filter implant and revision of total left hip replacement.The filter was implanted via the patient's right common femoral vein.The filter was placed below the level of the renal veins.There were no problems during the procedure.There was considerable lessening of the amount of thrombus in the deep venous system of the left lower extremity.There was still some residual thrombus in the left common femoral vein and proximal left superficial femoral vein.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported events approximately eleven years to twelve years after the index procedure.The patient continues to experience fear/emotional distress related to the filter.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of receipt.

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 perforation.The patient reported becoming aware of perforation of filter struts outside the inferior vena cava (ivc), approximately eleven years and six months post implant.The patient also reported anxiety related to the filter.According to the medical records the patient had a history of spinal deformity with harrington rod in place, neurofibromatosis, left total hip replacement.The indication for the filter implant was extensive pulmonary emboli, left leg deep vein thrombosis and need for revision of left total hip replacement that was dislocated after a fall from a chair.The filter was placed via the right common femoral vein and deployed below the level of the renal veins.Findings during the procedure noted, that due to the deformity of the spine the venous system was tortuous, and the right common iliac vein made a sharp angle into the confluence to the ivc.The ivc measured 18-20mm in the greatest dimension.A revision of left total hip replacement was performed during the hospitalization sometime after the filter was placed.The medical records note in the hospital course that the filter was removed.The product was not returned for analysis.The device history record review could not be completed.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.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 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 event could not be confirmed or further clarified.Anxiety does 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.

• Brand Name: OPTEASE RETRIEVAL 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 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15499263
• MDR Text Key: 300724346
• Report Number: 9616099-2022-06033
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1103014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 5 FRENCH SHEATH; UNKNOWN 5 FRENCH SHEATH; UNKNOWN 8 FRENCH SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 41 YR
• Patient Sex: Male