MAUDE Adverse Event Report: CORDIS CORPORATION JUGULAR 55CM KIT OPTEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	466FXXXX
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 organ perforation and tilt.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.Ivc filter tilt has been associated with operator technique and vessel anatomy, 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.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.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 or Problem Description
As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: organ perforation and tilt.As a direct and proximate result, 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 or Problem Description
As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: organ perforation and tilt.As a direct and proximate result, 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.The following additional information was received per the patient¿s implant records: the patient had a history of extensive acute dvt and extensive pulmonary embolism with relative contraindication to anticoagulation.The filter was implanted via the right internal jugular.The optease filter was deployed with its apex location below the renal veins.The ivc filter was placed without immediate complication.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 5 years and 3 months post implantation.The patient reports perforation of filter strut(s) outside the ivc, perforation of filter strut(s) into organs and filter tilt.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b5, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.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 organ perforation and tilt.The patient reported becoming aware of perforation of filter strut(s) outside the ivc and into organs and tilt, approximately five years and three months post implant.According to the medical record the indication for the filter implant was a history of extensive acute deep vein thrombosis (dvt) and extensive pulmonary embolism with a relative contraindication to anticoagulation.The filter was placed via the right internal jugular vein and deployed with the apex location below the renal veins, without immediate complication.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.Ivc filter tilt has been associated with operator technique and vessel anatomy, 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.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.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.
Additional 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 organ perforation and tilt.The patient reported becoming aware of perforation of filter strut(s) outside the ivc and into organs and tilt, approximately five years and three months post implant.According to the medical record the indication for the filter implant was a history of extensive acute deep vein thrombosis (dvt) and extensive pulmonary embolism with a relative contraindication to anticoagulation.The filter was placed via the right internal jugular vein and deployed with the apex location below the renal veins, without immediate complication.The patient has subsequently reported experiencing anxiety related to the filter.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.Ivc filter tilt has been associated with operator technique and vessel anatomy, 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.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.Without images available for review the reported events could not be confirmed or further clarified.Anxiety is an emotion characterized by an unpleasant state of inner turmoil, often accompanied by nervous behavior, somatic complaints, and rumination.The physiological symptoms of anxiety may include, but are not limited to neurological, respiratory, cardiac, muscular, and cutaneous.These symptoms of anxiety do 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.
Event or Problem Description
Additional information received per an amended patient profile form (ppf) states that the patient experienced anxiety related to the filter.

• Brand Name: JUGULAR 55CM KIT OPTEASE
• Common Device Name: 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: 13254299
• Report Number: 9616099-2022-05298
• Device Sequence Number: 4228942
• Product Code: DTK
• UDI-Device Identifier: 20705032072882
• UDI-Public: 20705032072882
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K034050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F230AJ
• Device Lot Number: 17066355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 02/28/2022; 04/04/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/23/2022; 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 0.035 WIRE; UNKNOWN 19-GAUGE SINGLE WALL NEEDLE; UNKNOWN 6 F SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 52 YR
• Patient Sex: Male