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

Catalog Number 466F220A

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

As reported, a patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement was not reported.The filter subsequently malfunctioned including filter tilt.The filter remains implanted; thus, unavailable for analysis.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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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 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 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 filter 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records the patient was reported to have a preoperative diagnosis of recurrent deep vein thrombosis (dvt) and developed contraindication to anticoagulation.The patient was prepped and draped in a sterile manner.Under local anesthesia, ultrasound guided access was used to enter the left femoral vein and a wire was passed into the inferior vena cava.A venacavogram was completed.The vena cava measured 19mm.The delivery device was passed to the level that was appropriate and the filter was delivered at this point.There was no significant movement of the filter.Final venacavography was carried out.The patient was taken to recovery room in stable condition.According to the information received in the patient profile form (ppf), the patient reports tilting of the filter, becoming aware of this event approximately nine years and six months after the filter implantation.The patient further asserts to have suffered from periodic groin pain post implant; inability to participate in sports, drive a motorcycle, chores and limited physical activities due to fatigue and the need for frequent naps; and experienced anxiety related to the filter.

Manufacturer Narrative

As reported, a patient underwent placement of an optease inferior vena cava (ivc) filter.Per the implant records, the indication was recurrent deep vein thrombosis (dvt) with acquired contraindication to anticoagulation.A venocavogram located the renal veins and assessed the caliber of the ivc.The filter was successfully deployed in an infrarenal position.There were no reports of complications.The filter malfunctioned including filter tilt.Per the patient profile form (ppf), the patient reports tilting of the filter, periodic groin pain, fatigue and anxiety related to the filter.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 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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Anxiety, fatigue and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 11677347
• MDR Text Key: 245818931
• Report Number: 1016427-2021-04898
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 466F220A
• Device Lot Number: 15320551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK MICRO WIRE, UNK 4FSHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR