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

Model Number 466F220A

Device Problems Fracture (1260); Unintended Movement (3026)

Patient Problems Hematoma (1884); Stenosis (2263); Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

Reporter 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 is tilted, embedded and filter fracture.The patient underwent a complicated removal surgery where an asymptomatic inferior vena cava (ivc) injury was discovered, ivc stenosis and two filter fragments were retained in the ivc wall.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.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implant.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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Stenosis is an abnormal narrowing of a vessel and does not represent a device malfunction.An unspecified injury was reported, due to the nature of the complaint the event could not be further clarified.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.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 also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu also states that filter fracture with perforation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.The timing and mechanism of the events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.Organ perforation was reported, without images available for review the reported events 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.(b)(4).Please note that this is the initial report for this product.

Event Description

As reported by the legal brief, the patient underwent placement of an 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 is tilted, embedded and filter fracture.The patient underwent a complicated removal surgery where an asymptomatic inferior vena cava (ivc) injury was discovered, ivc stenosis and two filter fragments were retained in the ivc wall.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

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 is tilted, embedded and filter fracture.The patient underwent a complicated removal surgery where an asymptomatic inferior vena cava (ivc) injury was discovered, ivc stenosis and two filter fragments were retained in the ivc wall.The patient reported becoming aware of the events approximately thirteen years post implant.The patient additionally reported chest pain and anxiety related to the filter.The patient also indicated that the filter was removed via an open chest procedure; however, the medical records indicate it was removed percutaneously.According to the medical record the patient was two weeks out from spinal fusion surgery and presented to the emergency department with a swollen left lower extremity (lle).Venous duplex ultrasound showed lle deep vein thrombosis (dvt) extending up to the inguinal ligament.The indication for the filter was dvt and a contraindication to lytic therapy.Initial access for the filter placement was the right common femoral vein.After advancing the catheter sheath into the right external iliac vein venography was performed and showed large, non-occlusive, free-floating thrombus extending up into the ivc from the left common iliac veins.It was then decided to place the filter from right internal jugular access.The filter was deployed below the renal veins and above the thrombus.The filter ended up tilted to the right, attempts to straighten it using an sos catheter were unsuccessful.A computerized tomography (ct) scan of the chest performed approximately twelve years and six months post implant showed no ivc fragments within the chest/pulmonary arterial vasculature.Ct of the abdomen showed a tilted ivc filter in the infrarenal ivc.Approximately thirteen years post implant the patient underwent percutaneous laser assisted ivc filter removal that was complicated by a retained tine of the filter and a small leak from the ivc on post procedure imaging.Post procedure remarks note retained fractured optease vena cava filter, patent ivc, retention of one vertical strut with the upper and lower stabilizing arms retained in the ivc.Minimal ivc stenosis with ivc injury of the right lateral wall with extravasation into the retroperitoneal space.The patient did have an episode of hypotension, most likely hypovolemic in nature.The extravasation resolved at 30 minutes with residual focal right lateral wall enlargement.The following day a repeat ct scan showed stable retroperitoneal hematoma.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 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.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implant.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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Stenosis is an abnormal narrowing of a vessel and does not represent a device malfunction.An unspecified injury was initially reported and has been clarified as a small leak from the ivc on post procedure imaging, likely resulting in a retroperitoneal hematoma.Retroperitoneal hematomas are an infrequent but serious complication of transfemoral percutaneous procedures.Retroperitoneal hematoma refers to an accumulation of blood found in the retroperitoneal space.This most often occurs due to a back-wall, high stick or manipulation of catheters and wires within the vasculature.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.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 also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu also states that filter fracture with perforation is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It is unknown if the fracture occurred during the removal attempt, as scans prior to the removal procedure did not report filter fracture.Chest pain and anxiety do 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

According to the medical record the patient was two weeks out from spinal fusion surgery and presented to the emergency department with a swollen left lower extremity (lle).Venous duplex ultrasound showed lle deep vein thrombosis (dvt) extending up to the inguinal ligament.The indication for the filter was dvt and a contraindication to lytic therapy.Initial access for the filter placement was the right common femoral vein.After advancing the catheter sheath into the right external iliac vein venography was performed and showed large, non-occlusive, free-floating thrombus extending up into the inferior vena cava (ivc) from the left common iliac veins.It was then decided to place the filter from right internal jugular access.The filter was deployed below the renal veins and above the thrombus.The filter ended up tilted to the right, attempts to straighten it using an sos catheter were unsuccessful.A computerized tomography (ct) scan of the chest performed approximately twelve years and six months post implant showed no ivc fragments within the chest/pulmonary arterial vasculature.Ct of the abdomen showed a tilted ivc filter in the infrarenal ivc.Approximately thirteen years post implant the patient underwent percutaneous laser assisted ivc filter removal that was complicated by a retained tine of the filter and a small leak from the ivc on post procedure imaging.Post procedure remarks note retained fractured optease vena cava filter, patent ivc, retention of one vertical strut with the upper and lower stabilizing arms retained in the ivc.Minimal ivc stenosis with ivc injury of the right lateral wall with extravasation into the retroperitoneal space.The patient did have an episode of hypotension, most likely hypovolemic in nature.The extravasation resolved at 30 minutes with residual focal right lateral wall enlargement.The following day a repeat ct scan showed stable retroperitoneal hematoma.Incidental findings noted basilar atelectasis in the right lung base and a liver lesion, likely a cyst or hemangioma.According to the patient profile form, the patient reported becoming aware of fracture, tilt, and filter embedment approximately thirteen years post implant.The patient additionally reported chest pain and anxiety related to the filter.The patient also indicated that the filter was removed via an open chest procedure; however, the medical records indicate it was removed percutaneously.

• 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 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12256261
• MDR Text Key: 264467730
• Report Number: 1016427-2021-05196
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• 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
• Device Lot Number: R0906250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK BENTSON 0.35; UNK BERENSTEIN, UNK 145CM COOK
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female