MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 06/17/2013

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 failed filter removal due to filter tilt and embedment.The indication for the filter implant and procedural details have not been provided.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures and has been shown to occur in as short a period as 12 days.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and retrieval difficulty due to embedment could not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with vessel characteristics, specifically asymmetry, tortuosity and implant technique.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, failed filter removal due to filter tilt and embedment.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 Description

As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, failed filter removal due to filter tilt and embedment.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.Per the implant records, the patient was reported to have a history of previous pulmonary embolus (pe).The request for placement of the inferior vena cava filter was prophylactic for preoperative gynecologic surgery.The right neck was prepped and draped in the usual sterile fashion.The arms could not be utilized due to edema; and the inguinal regions were more difficult to utilize because of the presence of a mesh in the vicinity of the right lower quadrant.Using direct sonographic guidance, a micro puncture needle was advanced into the right internal jugular vein and a wire was advanced centrally; a sheath was placed, and the patient received intravenous conscious sedation.The inferior vena cava (ivc) venography revealed a vena cava of normal caliber, measuring 24mm.There was no filling defect and normal anatomy.The optease cordis filter was then placed in the infrarenal ivc without complication.The patient tolerated the procedure well and was discharged in a stable and satisfactory condition two hours post procedure.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately four years and eleven months after the filter implantation.The patient reports filter tilting and embedded in wall of the ivc, device unable to be retrieved with an unsuccessful percutaneous removal procedure attempt approximately one month and twenty-two days after the filter was implanted.The patient further experienced anguish, anxiety and chest pain related to the filter.

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 failed filter removal due to filter tilt and embedment.The patient reported filter tilt, embedded in wall of the ivc, and device unable to be retrieved with an unsuccessful percutaneous removal attempt occurring approximately one month and twenty-two days post implant, anxiety and chest pain related to the filter.The patient reported becoming aware of these events approximately four years and eleven months post implant.According to the implant record the indication for the filter implant was prophylactic prior to gynecology surgery in a patient with a history of pulmonary embolism.The arms could not be utilized due to edema; and the inguinal regions were more difficult to utilize because of the presence of a mesh in the vicinity of the right lower quadrant.The filter was placed via the right internal jugular vein and deployed in the infrarenal ivc without complication.The patient tolerated the procedure well and was discharged in a stable and satisfactory condition two hours post procedure.There is currently no additional information available for review.The product was not returned 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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures and has been shown to occur in as short a period as 12 days.Post implant imaging has not been provided.Without the procedural films or post-placement imaging and the limited information provided, the report of tilt and retrieval difficulty due to embedment could not be confirmed or further clarified.Additionally, the timing and mechanism of the filter tilt is unknown, it is unknown if the tilt occurred during the retrieval attempt.Ivc filter tilt has been associated with vessel characteristics, specifically asymmetry, tortuosity and implant technique.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, there is nothing to suggest that a malfunction in 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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10115272
• MDR Text Key: 193944887
• Report Number: 1016427-2020-04005
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220B
• Device Lot Number: 15798681
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 5F MARKER CATHETER; UNK 6F SHEATH; UNK MICRO PUNCTURE NEEDLE; UNK WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR