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

Model Number	466F230AF
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.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 filter is tilted, abuts the inferior vena cava (ivc) wall and 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.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.Please note that this is the initial report for this product.
Event or Problem 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 the filter is tilted, abuts the inferior vena cava (ivc) wall and perforates the ivc wall.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.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: b4, d4, g3, g6, h1, h2 and h4.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 is tilted, abuts the inferior vena cava (ivc) wall and perforates the ivc wall.The patient reported becoming aware of the events approximately three years and five months post implant.The patient also reported chest pain related to the tilted filter.According to the medical records the patient had a history of morbid obesity and hypercoagulable state.The indication for the filter placement was prophylaxis prior to gastric bypass surgery due to a high risk for thromboembolism.The filter was placed via the right common femoral vein and was deployed at the l2-l3 intervertebral disk.Approximately eight months later a computed tomography (ct) scan of the abdomen was performed, the indication for the exam was not provided.Results noted the filter is in place, a 3cm right adnexal cyst, small fat containing ventral hernia and diffuse significant fatty liver.One year and four months later a duplex ultrasound of the lower extremities was performed.History noted at the time of the exam was elevated d-dimer, anemia and anxiety.The exam was negative for deep vein thrombosis.Approximately three years and five months post implant an abdominal ct scan was performed for abdominal pain.Results of the scan noted the filter is tilted and one leg of the filter questionably projects beyond the ivc.The filter appears intact.The liver was noted to appear normal in this scan.The product is 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.Abdominal and chest pain do not represent a device malfunction and may be related to underlying patient specific issues and 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.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days of receipt.Section d6a per the medical records, the correct implant date was january 25, 2016.
Event or Problem Description
Additional information received per the medical records indicate that the patient has a history of morbid obesity and hypercoagulable state.The indication for the filter placement was prophylaxis prior to gastric bypass surgery due to a high risk for thromboembolism.The filter was placed via the right common femoral vein and was deployed at the l2-l3 intervertebral disk.Approximately eight months later a computed tomography (ct) scan of the abdomen was performed, the indication for the exam was not provided.Results noted the filter is in place, a 3cm right adnexal cyst, small fat containing ventral hernia and diffuse significant fatty liver.One year and four months later a duplex ultrasound of the lower extremities was performed.History noted at the time of the exam was elevated d-dimer, anemia and anxiety.The exam was negative for deep vein thrombosis.Approximately three years and five months post implant an abdominal ct scan was performed for abdominal pain.Results of the scan noted the filter is tilted and one leg of the filter questionably projects beyond the ivc.The filter appears intact.The liver was noted to appear normal in this scan.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt and perforation of filter strut(s) outside the ivc.The patient became aware of the reported events approximately three years and five months after the index procedure.The patient also reported chest pain related to the tilted filter.

• Brand Name: FEMORAL 55CM KIT
• 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 FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12264567
• Report Number: 1016427-2021-05223
• Device Sequence Number: 4255169
• Product Code: DTK
• UDI-Device Identifier: 20705032072899
• UDI-Public: 20705032072899
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2022

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: 07/31/2018
• Device Model Number: 466F230AF
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17322278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 06/09/2022; 07/11/2022
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 07/13/2022; 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 174 KG