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

Model Number 466F220A

Device Problems Failure to Align (2522); Therapeutic or Diagnostic Output Failure (3023); Unintended Movement (3026)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 08/18/2022

Event Type  Injury  

Event Description

As reported by the legal brief, the patient underwent placement of av 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 filter perforation.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

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 perforation.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.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 notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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.Please note that this is the initial report for this product.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b1, b3, b4, b5, b6, b7, d1, d4, d10, g2, 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 perforation.The patient reported becoming aware of perforation of filter struts outside the inferior vena cava (ivc) wall and right filter tilt with the cone against the ivc wall, approximately sixteen years and four months post implant.The patient also reported anxiety related to the filter.According to the medical records the indication for the filter placement was prophylactically prior to planned bariatric surgery in a morbidly obese patient, at high risk for deep vein thrombosis and pulmonary embolus.The filter was implanted via the right jugular vein and deployed in the ivc after the renal veins were identified.A completion venogram was performed, and the filter was found to be "a little tilted," but otherwise in good position.The sheath was removed, and a triple lumen catheter was placed in the venipuncture hole.The patient tolerated the procedure well and was delivered for bariatric surgery.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.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 notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Without images available for review the reported events could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues or other undisclosed 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 morbid obesity with planned bariatric surgery and a high risk for development of deep vein thrombosis and pulmonary embolism (pe).The filter was implanted via the patient's right jugular vein.A wire was inserted to the level of the inferior vena cava (ivc) bifurcation under fluoroscopic guidance.A 40 cm sheath was placed and anchored at the level of l2.A pigtail catheter was placed within the sheath and a venogram was performed.The renal veins were identified and the jugular vein sheath was used to place the filter.A completion venogram was performed, and the filter was found to be "a little tilted," but otherwise in good position.The sheath was removed and a triple lumen catheter was placed in the venipuncture hole.The patient tolerated the procedure well and was delivered for bariatric surgery.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter six struts outside the inferior vena cava (ivc) wall and right filter tilt with the cone against the ivc wall.The patient became aware of the reported events approximately sixteen years and four months after the index procedure.The patient also experienced anxiety (stress, mental distress, emotional distress, anguish, anger, fear, sleeplessness) related to the filter.

• Brand Name: OPTEASE RETRIEVAL FILTER
• 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: 15327368
• MDR Text Key: 298990236
• Report Number: 9616099-2022-05934
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 6 FRENCH PIGTAIL CATHETER; CORDIS GUIDE WIRE; UNKNOWN 40 CM SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female