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

Model Number 466F220A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

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

Event Date 06/26/2019

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: filter perforates the ivc wall.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 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.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 by the legal brief, the patient underwent placement of an unknown optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: filter perforates the ivc wall.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 perforation of the inferior vena cava (ivc) wall.The patient reported becoming aware of perforation of filter strut(s) into organs approximately ten years and five months post implant.The patient also reported pain related to the tilted ivc filter.The indication for the filter implant was not provided.The filter was implanted via the right internal jugular vein and was deployed without difficulty at the l3 level.A subsequent contrast injection shows the filter below the level of the renal veins and above the iliac bifurcation.Approximately ten years and four months post implant an abdominal computed tomography (ct) scan was done for an unspecified injury to the inferior vena cava (ivc).Results of the scan noted the filter struts appear to extend beyond the ivc wall/lumen, the filter appears intact.There is no obvious adjacent structure penetration.The ivc above and below the filter is normal in caliber.Incidental findings noted mild bibasilar dependent and subsegmental bibasilar atelectasis, a nonspecific 9mm hypodensity in the lower pole of the right kidney (this may represent a hyperdense cyst), atherosclerotic normal caliber abdominal aorta and degenerative changes in spine.The product remains implant and therefore not available 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.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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.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 or undisclosed comorbidities.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 filter was implanted via the patient's right internal jugular vein.A venocavogram was performed and the renal veins were located.The filter was inserted into the sheath and was deployed without difficulty at the l3 level.A subsequent contract injection shows the filter below the level of the renal veins and above the iliac bifurcation.Approximately ten years and four months after the index procedure an abdominal computed tomography (ct) scan was done for an unspecified injury to the inferior vena cava (ivc).The images revealed: lung bases demonstrate mild bibasilar depended and subsegmental atelectasis, nonspecific 9mm hypodensity in the lower pole of the right kidney (this may represent a hyperdense cyst), the filter struts appear to extend beyond the ivc wall/lumen, the filter appears intact, atherosclerotic normal caliber abdominal aorta and degenerative changes in spine.There is no obvious adjacent structure penetration.The ivc above and below the filter is normal in caliber.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) into organs.The patient became aware of the reported events approximately ten years and five months after the index procedure.The patient also reported filter tilt and feeling pain related to the filter.

• 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 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12227048
• MDR Text Key: 263510759
• Report Number: 1016427-2021-05124
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R0408552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2008
• 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
• Treatment: UNKNOWN 0.18 GUIDE WIRE; UNKNOWN 0.35 GUIDE WIRE; UNKNOWN 4 FRENCH SHEATH; UNKNOWN 5 FRENCH PIGTAIL CATHETER; UNKNOWN INTRODUCER; UNKNOWN SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female