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

Model Number 466F220B

Device Problems Filling Problem (1233); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/12/2006

Event Type  Injury  

Manufacturer Narrative

Information was received that indicated a patient underwent placement of an optease inferior vena cava (ivc) filter and experienced thrombus in the filter.According to the medical records, prior to the index procedure the patient suffered an epigastric stab wound, and underwent exploratory laparotomy, sternotomy with exploration of pericardium, veno-veno bypass, biomedicus pump, repair of liver laceration and exploration of retroperitoneal hematoma with placement of right chest tube.The patient's medical history is notable for factor v leiden, deep vein thrombosis (dvt) while on coumadin, (b)(6), depression, asthma, chronic pain and substance abuse.Per the implant records, the patient was reported to have a preoperative diagnosis of pseudoaneurysm and was implanted with a temporary optease inferior vena cava (ivc) filter without any complications.Six days post implant a venacavagram was performed and demonstrated an elongated filling defect within the filter seen on both obliquities.The filling defect is not occlusive, but nevertheless is quite sizable.Fragmin therapy was recommended prior to filter removal attempt.A month later the venacavagram was repeated and demonstrated persistence of the elongated filling defect within the filter.The filling defect is nonocclusive.The report noted that removal of the ivc filter was not possible due to the filling defect and length of time since insertion (approximately five months).Approximately twenty-two months post implant the patient underwent a consultation for swelling of the right leg with pain.A venous doppler study showed chronic nonocclusive thrombi in the right superficial, greater saphenous and popliteal veins.The patient was reported to be doing well wearing compression stockings and taking pain medication.About two months later, the patient was seen by vascular for a history of dvt, swelling of right leg with pain and had another vascular consultation one month later for same symptoms.The physician felt the pain in the leg was musculoskeletal and not related to dvt.The physician also noted that the filter could not be removed.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 ivc 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/or occlusive thrombosis within the filter and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.With the limited information provided a clinical determination cannot be made as to what factors may have contributed to the reported events.There is nothing to suggest that the reported events are related to the design and/or 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

According to the medical records, prior to the index procedure the patient suffered an epigastric stab wound, and underwent exploratory laparotomy, sternotomy with exploration of pericardium, veno-veno bypass, biomedicus pump, repair of liver laceration and exploration of retroperitoneal hematoma with placement of right chest tube.The patient's medical history is notable for factor v leiden, deep vein thrombosis (dvt) while on coumadin, (b)(6), depression, asthma, chronic pain and substance abuse.Per the implant records, the patient was reported to have a preoperative diagnosis of pseudoaneurysm, and was implanted with a temporary optease inferior vena cava (ivc) filter without any complications.Six days after the filter was implanted, a venacavagram was performed, demonstrating an elongated filling defect within the filter seen on both obliquities.The filling defect is not occlusive, but nevertheless is quite sizable.Fragmin therapy was recommended prior to filter removal attempt.A month later, the venacavagram was repeated and demonstrated persistence of the elongated filling defect within the previously inserted optease filter.The filling defect is nonocclusive.The report noted that removal of the ivc filter was not possible due to the filling defect and length of time since insertion (approximately five months).About a year and ten months after the filter was implanted, the patient underwent a consultation for swelling of the right leg with pain.A venous doppler study showed chronic nonocclusive thrombi in the right superficial vein, right greater saphenous vein and popliteal vein.The patient was reported to be doing well wearing compression stockings and taking pain medication.About two months later, the patient was seen by vascular for a history of dvt, swelling of right leg with pain and had another vascular consultation one month later for same symptoms.The physician felt the pain in the leg was musculoskeletal and not related to dvt.The physician also noted that the filter could not be removed.

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have had a history of factor v leiden, deep vein thrombosis (dvt) despite anticoagulation therapy, hepatitis, depression, asthma, chronic pain and substance abuse.At some point prior to the filter implantation, the patient experienced an epigastric stab wound requiring exploratory laparotomy and sternotomy.This surgery involved cardiopulmonary bypass, repair of a liver laceration and exploration of a retroperitoneal hematoma requiring placement of a chest tube.The patient presented to hospital with bilateral lower extremity dvt within the right superficial femoral vein.The indication for the filter placement was not reported.The filter was implanted via the right femoral vein and placed in an infrarenal position without complications.Six days after the filter implantation, the patient underwent diagnostic testing that revealed that there was a sizable elongated non-flow limiting filling defect within the filter.Fragmin therapy was recommended prior to the filter retrieval.Approximately forty-three days after the filter implantation, repeat diagnostic testing revealed an essentially unchanged filling defect within the filter.Filter removed was deferred at that time.Approximately five months after the filter implantation, diagnostic testing again revealed the persistent elongated non-occlusive limiting filling defect within the filter.The report of this procedure noted that removal at the filter at that time was not possible due to the filling defect and the length of time since the filter implantation.Approximately one year and ten months after the filter implantation, the patient developed swelling and pain of the right lower extremity.Diagnostic testing revealed chronic non-occlusive thrombi within the right superficial, greater saphenous and popliteal veins.The patient reported having been compliant with compression stockings and medications.Approximately two years after the filter implantation, the patient presented for vascular consult for a history of dvt, right lower extremity pain and swelling and for a second vascular consult one month later.The patient¿s physician felt that the pain was musculoskeletal in origin and unrelated to dvt.The physician further noted that the filter was irretrievable.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.Thrombosis within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.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

The patient is reported to have a history of dvt and prior to the index procedure, results of a bilateral lower extremity ultrasound showed a recent dvt within the mid and right lower superficial femoral vein.Per the operative report, the right femoral vein was punctured followed by placement of a sheath, and a guidewire and catheter were used to select the right and left renal veins.Digital subtraction angiography was used to obtain a cavogram.An optease vena cava filter was placed below the level of the renal veins.Contrast injection following placement of the filter demonstrated appropriate positioning.There were no complications.The review of the additional medical records provided revealed that about three days after the filter was implanted, the patient underwent an abdominal ultrasound.The report noted that the gallbladder had been surgically removed, in addition to a hypoechoic lesion on the left lobe of the liver (related to injury) and a simple cyst within the midpole of the right kidney.Approximately a month after the filter was implanted, an abdominal x-ray was performed for persistent pain post laparotomy for stab wound, and gastric distention was observed.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 11919094
• MDR Text Key: 253809284
• Report Number: 1016427-2021-05005
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009420
• UDI-Public: 20705032009420
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2009
• Device Model Number: 466F220B
• Device Catalogue Number: 466F220B
• Device Lot Number: R0506271
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK CATHETER, UNK SHEATH, UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR