MAUDE Adverse Event Report: CORDIS CORPORATION 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problems Difficult to Remove (1528); Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984)

Event Date 08/27/2018

Event Type  Injury  

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 the filter and an attempt to reposition the filter was difficult as the filter was embedded and irretrievable.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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.The timing and mechanism of the migration and retrieval difficulty 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 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 migration of the filter and an attempt to reposition the filter.Repositioning was difficult as the filter was embedded and irretrievable.

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.According to the information received in the patient profile form, the patient reports filter migration, blood clots, clotting and or occlusion of the ivc, in addition to an unsuccessful percutaneous retrieval attempt approximately twenty-eight days after the filter implantation.The patient further experienced anxiety and fear related to the filter causing further damage as it has not been safely removed.According to the medical records, a day prior to the index procedure, the patient presented to the emergency room with chest pain and shortness of breath, onset of 4 hours.A computed tomography (ct) scan of the chest revealed extensive acute pulmonary emboli to the lower lobes and right upper lobe predominately with clot identified in the left upper lobe as well.Venous ultrasound (u/s) identified an acute left mid femoral deep vein thrombosis (dvt) extending into the left popliteal vein.Per the implant records, using a micro puncture kit and ultrasound guidance, right common venous access was obtained.The renal veins were identified using digital subtraction angiography (dsa).An optease ivc filter was deployed in good position followed by successful placement of bilateral ekos catheters in the right and left pulmonary arteries.The patient was discharged home three days after admission.Approximately twenty-eight days after the filter was implanted, the patient underwent an attempted percutaneous removal of the filter.Using u/s guidance the right greater saphenous vein was accessed with a micropuncture kit, followed by an 8f destination sheath.A jr4 diagnostic catheter and a 10mm and 30mm snare were used in an attempt to retrieve the filter.The filter had migrated caudally and the hook was now in the right iliac vein.It was endothelialized a great bit, an attempt was made to reposition with a 7 f swan-ganz catheter, but was unable to unroof the hook from the endothelialized left iliac vein.The filter was brought caudally with hook in the right iliac vein, the body of the filter straddles both iliac veins.There were no complications.Approximately twenty-six months post implant, the patient underwent an abdominal ct scan for evaluation of the ivc filter.Results of the scan noted that the ivc filter is positioned below the level of the renal veins, no significant tilt, no bending or breaking of the device, no struts extending beyond the vessel wall and no retroperitoneal hemorrhage or stenosis.Impression: ivc filter in place with no apparent complication.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 optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.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.It is uncertain if the filter was migrated during the retrieval attempt.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.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

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 migration of the filter and an attempt to reposition the filter.Repositioning was difficult as the filter was embedded and irretrievable.According to the medical records, a day prior to the index procedure, the patient presented to the emergency room with chest pain and shortness of breath, onset of 4 hours.A computed tomography (ct) scan of the chest revealed extensive acute pulmonary emboli to the lower lobes and right upper lobe predominately with clot identified in the left upper lobe as well.Venous ultrasound (u/s) identified an acute left mid femoral deep vein thrombosis (dvt) extending into the left popliteal vein.Per the implant records, using a micro puncture kit and ultrasound guidance, right common venous access was obtained.The renal veins were identified using digital subtraction angiography (dsa).An optease ivc filter was deployed in good position followed by successful placement of bilateral ekos catheters in the right and left pulmonary arteries.The patient was discharged home three days after admission.Approximately twenty-eight days after the filter was implanted, the patient underwent an attempted percutaneous removal of the filter indicated for sub massive pulmonary embolus with cor pulmonale and left lower extremity (lle) dvt.Using u/s guidance the right greater saphenous vein was accessed with a micropuncture kit, followed by an 8f destination sheath.A jr4 diagnostic catheter and a 10mm and 30mm snare were used in an attempt to retrieve the filter.The filter had migrated caudally and the hook was not in the right iliac vein.It was endothelialized a great bit, an attempt was made to reposition with a 7 f swan-ganz catheter, but the surgeon was unable to unroof the hook from the endothelialized left iliac vein.The filter was brought caudally with hook in the right iliac vein, the body of the filter straddles both iliac veins.There were no complications.Approximately two years and two months post implant, the patient underwent an abdominal ct scan for evaluation of the ivc filter.Results of the scan noted that the ivc filter is positioned below the level of the renal veins, not significant tilt, no bending or breaking of the device, no struts extending beyond the vessel wall and no retroperitoneal hemorrhage or stenosis.Impression: ivc filter in place with no apparent complication.According to the information received in the patient profile form (ppf), the patient reports filter migration, blood clots, clotting and or occlusion of the ivc, in addition to an unsuccessful percutaneous retrieval attempt approximately twenty-eight days after the filter implantation.The patient further experienced anxiety and fear related to the filter causing further damage as it has not been safely removed.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• MDR Report Key: 10275705
• MDR Text Key: 199119718
• Report Number: 1016427-2020-04201
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 466F230AF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8F BRITE TIP; UNK 6F SHEATH; UNK COOK MICROPUNCTURE
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR