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

Model Number 466FXXXX

Device Problems Failure to Align (2522); Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: 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 migration of inferior vena cava (ivc) filter located in the lower ivc with the inferior tip in the right iliac vein.The indication for the filter implant and medical/procedural records 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 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.The timing and mechanism of the migration has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.With the very limited information provided and without the procedural films or post implant images to review the reported events could not be further clarified.Given the limited information currently available for review, 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 by the legal brief, the patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: the patient suffered physical and emotional damages from a migration of ivc filter located in the lower ivc with the inferior tip in the right iliac vein.As a direct and proximate result of these malfunctions, patient suffered life-threatening injuries and damages, and required extensive medical care and treatment.As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.

Event Description

Additional information received from an amended patient profile form (ppf) states that the patient became aware of the reported events approximately four years and five months after the index procedure.

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 migration of inferior vena cava (ivc) filter located in the lower ivc with the inferior tip in the right iliac vein.The patient reported tilt, filter embedded other than in wall of the inferior vena cava (ivc), malposition of filter tip and filter tip perforating the right iliac vein.The patient also reported experiencing mental anguish, worry and anxiety.Additional information received states that the patient became aware of the reported events approximately four years and five months post implant.According to the medical records the patient has a history of hypertension and tobacco abuse.The records indicate that three days before the implant, the patient presented to the emergency room with a non-st myocardial infarction.Two days before the implant, the patient underwent coronary artery bypass grafting x 4.Later that day, into the following day the patient returned to the operating room for mediastinal exploration and evacuation of clot.The next day the patient was implanted with the filter.The indication for the filter implant was bilateral deep vein thrombosis (dvt) with suspected pulmonary embolism (pe) and contraindication to anticoagulation due to a rebleeding episode following open heart surgery.The filter was implanted via the left internal jugular vein and was deployed below the level of the renal veins.Successful deployment was identified on fluoroscopy in order to limit the amount of contrast, no post placement cavogram was performed.The orientation of the device was satisfactory.The patient was discharged to home twelve days after admission.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number provided is illegible; 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.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 and has been shown to occur in as short a period as 12 days.Ivc filter tilt has been associated with the anatomy of the vessel, 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.Due to the nature of the complaint the reported malposition of the filter tip could not be further clarified.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.With the very limited information provided and without the procedural films or post implant images to review the reported events could not be further clarified nor a cause determined.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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 states that the patient has a history of hypertension and tobacco abuse.The records indicate that three days before the implant, the patient presented to the emergency room with a non-st myocardial infarction.Two days before the implant, the patient underwent coronary artery bypass grafting x 4.Later that day, into the following day the patient returned to the operating room for mediastinal exploration and evacuation of clot.The next day the patient was implanted with the filter.The indication for the filter implant was bilateral deep vein thrombosis (dvt) with suspected pulmonary embolism (pe) and contraindication to anticoagulation due to a rebleeding episode following open heart surgery.The filter was implanted via the left internal jugular vein and was deployed below the level of the renal veins.Successful deployment was identified on fluoroscopy in order to limit the amount of contrast, no post placement cavogram was performed.The orientation of the device was satisfactory.The patient was discharged to home twelve days after admission.  additional information received per the patient profile form (ppf) states that the patient experienced tilt, filter embedded other than in wall of the inferior vena cava (ivc), malposition of filter tip and filter tip perforating the right iliac vein.The patient continues to experience mental anguish, worry and anxiety.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, a4, a5, b1, b4, b5, b7, d1, d4, d11, g3, g4, g7, 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 migration of inferior vena cava (ivc) filter located in the lower ivc with the inferior tip in the right iliac vein.The patient reported tilt, filter embedded other than in wall of the inferior vena cava (ivc), malposition of filter tip and filter tip perforating the right iliac vein.The patient also reported experiencing mental anguish, worry and anxiety.According to the medical records the patient has a history of hypertension and tobacco abuse.The records indicate that three days before the implant, the patient presented to the emergency room with a non-st myocardial infarction.Two days before the implant, the patient underwent coronary artery bypass grafting x 4.Later that day, into the following day the patient returned to the operating room for mediastinal exploration and evacuation of clot.The next day the patient was implanted with the filter.The indication for the filter implant was bilateral deep vein thrombosis (dvt) with suspected pulmonary embolism (pe) and contraindication to anticoagulation due to a rebleeding episode following open heart surgery.The filter was implanted via the left internal jugular vein and was deployed below the level of the renal veins.Successful deployment was identified on fluoroscopy in order to limit the amount of contrast, no post placement cavogram was performed.The orientation of the device was satisfactory.The patient was discharged to home twelve days after admission.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number provided is illegible; 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.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 and has been shown to occur in as short a period as 12 days.Ivc filter tilt has been associated with the anatomy of the vessel, 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.Due to the nature of the complaint the reported malposition of the filter tip could not be further clarified.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.With the very limited information provided and without the procedural films or post implant images to review the reported events could not be further clarified nor a cause determined.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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 60 avenue; miami lakes FL 33014
• MDR Report Key: 10322373
• MDR Text Key: 200426823
• Report Number: 1016427-2020-04227
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN J-WIRE; UNKNOWN MICROPUNCTURE INTRODUCER SYSTEM
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR
• Patient Weight: 95