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

Model Number 466F220B

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/03/2021

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 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.Without images available for review the reported event 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 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 filter tilting.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 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: 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.The patient reported becoming aware of filter tilt approximately seven years and six months post implant.The patient also reported pain in the groin area and anxiety related to the filter.According to the medical record the indication for the filter implant was a history of pulmonary embolism and a planned abdominal surgery directly following the filter implant.The filter was implanted via the right femoral approach and deployed in a "nice orientation for retrieval¿.Prior to deployment a venocavogram was performed which showed the location below the renals, there were no intracaval clots and the cava was of adequate size.Pressure was held at the access site, followed by a 4.0 vicryl suture.The patient tolerated the procedure well.Subsequently the patient was turned over to another doctor for the abdominal surgery.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.Without images available for review the reported event could not be confirmed or further clarified.Groin pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues or other 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 patient has a history of pulmonary embolism (pe).The filter was implanted prior to a planned abdominal surgical procedure.The filter was implanted via the right side femoral approach.A wire was inserted under fluoroscopic guidance, next a dilator and sheath were inserted.A venocavogram was performed which showed the location below the renals, there were no intracaval clots and the cava was of adequate size.Next the filter was deployed in a "nice orientation for retrieval." the patient tolerated the procedure well.Subsequently the patient was turned over to another doctor for a planned abdominal surgery.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 seven years and six months after the index procedure.The patient also experienced pain (groin area) and anxiety (psychological damage and stress) related to the filter.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, a3, b3, b4, b5, b7, d1, d4, d10, g2, g3, g6, h1, h2 and h4.Additional information is pending and will be submitted within 30 days of receipt.P section a3: p p.The patient is male.Br p.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 13176215
• MDR Text Key: 283474446
• Report Number: 9616099-2022-05262
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009420
• UDI-Public: 20705032009420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 466F220B
• Device Catalogue Number: 466F220B
• Device Lot Number: 15820539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2013
• 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: UNK.; UNKNOWN DILATOR.; UNKNOWN SHEATH.; UNKNOWN WIRE.
• Patient Outcome(s): Life Threatening
• Patient Age: 41 YR
• Patient Sex: Male