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

Model Number 466F230AF

Device Problem Unintended Movement (3026)

Patient Problems Coagulation Disorder (1779); Pain (1994); Unspecified Tissue Injury (4559)

Event Date 10/12/2020

Event Type  Injury  

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 tilt and pain.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.Without images available for review the reported event could not be confirmed or further clarified.Due to the nature of the complaint the reported pain could not be further clarified.Pain 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.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 tilt and pain.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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b5, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

Additional information received per the medical records indicate that the filter was implanted via the patient's right common femoral vein.The filter sheath was advanced to the l1-l2 level and then the filter was deployed.There were no immediate post procedural complications.Additional information received per the patient profile form (ppf) states that the patient experienced filter tilt.The patient became aware of the reported event approximately two years and two months after the index procedure.The patient also experienced blood clots, pain (chest and general) and anxiety (treated with medication).

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: b4, g3, g6, h1, h2 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 filter tilt and pain.The patient reported becoming aware of filter tilt approximately two years and two months post implant.The patient also reported blood clots, pain (chest and general) and anxiety, treated medically, related to the filter.The indication for the filter implant was not documented in the medical record.The filter was implanted via the right common femoral vein and deployed at the l1-l2 level and then the filter was deployed.There were no immediate post procedural complications.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.Blood clots, clotting and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Without images available for review the reported event could not be confirmed or further clarified.Due to the nature of the complaint the reported pain could not be 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.Pain and 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.

• Brand Name: FEMORAL 55CM KIT
• 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: 13669040
• MDR Text Key: 291309231
• Report Number: 9616099-2022-05395
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032072899
• UDI-Public: 20705032072899
• 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,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 466F230AF
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17411786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN 5 FRENCH MARKER PIGTAIL CATHETER.; UNKNOWN CATHETER.; UNKNOWN FILTER SHEATH.; UNKNOWN J-WIRE.; UNKNOWN MICROPUNCTURE NEEDLE.; UNKNOWN MICROSHEATH.; UNKNOWN MICROWIRE.
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female