MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Unintended Movement (3026)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Edema (1820); Embolus (1830); Occlusion (1984); No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent a surgical procedure to implant an optease retrievable vena cava filter for the treatment of recurrent deep venous thrombosis (dvt).The device was implanted into the patient¿s l1 level of the inferior vena cava (ivc).The device was positively identified by the patient¿s medical records.On or about three years after procedure, the patient received a scan on the ivc filter, which noted the ivc filter was now at the l2-l3 level.On or about one month and fifteen days post scan, the patient was notified by physicians that her ivc filter was at high risk if it was to be removed.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside her body.The product was not returned for analysis.Additionally, as the sterile lot number was not available, the device history record (dhr) review could not be performed.The optease inferior 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.Without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined.Giving the limited information available at this time, clinical factor contributing to the migration could not be determined.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 includes 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.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and/or manufacturing process of the device.Therefore no corrective action will be taken.

Event Description

As reported by the legal brief, the patient on or about (b)(6) 2013 underwent a surgical procedure to implant an optease retrievable vena cava filter for the treatment of recurrent deep venous thrombosis (dvt).The device was implanted into the patient¿s l1 level of the inferior vena cava (ivc).The device was positively identified by the patient¿s medical records.On or about (b)(6) 2016, the patient received a scan on the ivc filter, which noted the ivc filter was now at the l2-l3 level.On or about (b)(6) 2016, the patient was notified by physicians that her ivc filter was at high risk if it was to be removed.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the trapease filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside her body.

Manufacturer Narrative

As reported, the patient underwent a surgical procedure to implant a vena cava filter for the treatment of recurrent deep venous thrombosis (dvt).The device was implanted into the patient¿s l1 level of the inferior vena cava (ivc).The device was positively identified by the patient¿s medical records.On or about three years after procedure, the patient received a scan on the ivc filter, which noted the ivc filter was now at the l2-l3 level.On or about one month and fifteen days post scan, the patient was notified by physicians that her ivc filter was at high risk if it was to be removed.As of the present, the patient is still implanted with the device, which is known to be dangerous and cause serious side effects.As the result of the filter¿s installation, the patient has suffered and is at risk of suffering injuries, possibly permanent and life-threatening, and will require extensive medical care, monitoring and treatment.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses, not limited to the apprehension and risk associated with retaining a defective device inside her body.Brand name was corrected to 'unknown vena cava filter'catalog number was corrected to 'unk filter', pma/510(k)number corrected to 'unknown',updated complaint conclusion: the product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The inferior 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.Blood clots and thrombosis/occlusion within ivc does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined.Giving the limited information available at this time, clinical factor contributing to the migration could not be determined.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 includes 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.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.

Manufacturer Narrative

It was reported that a patient had an optease vena cava filter implanted.The information provided alleges that the device had migrated, can¿t be retrieved (there are no known recorded attempts to retrieve the device) and there are blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The patient is also reported to be experiencing anxiety, leg edema, chest pain and difficulty walking.The indication for the filter implant was recurrent deep vein thrombosis (dvt) despite anticoagulation therapy.The patient¿s medical history consists of hypertension, asthma, hypothyroidism, gastric ulcer and hyperlipidemia, previous back surgery, sleep apnea, cardiac murmur, obesity and chronic pain syndrome.The filter was implanted via the right internal jugular vein, as it was not possible to pass a wire via the right groin approach do to total occlusion of the iliac vein with extensive collateralization in the pelvic area and reconstitution of the ivc superiorly.The device was then deployed at the l1 level of the inferior vena cava (ivc).Approximately three years and one-month post implant the patient was evaluated for angina and possible removal of the filter.The evaluation noted possible gastro-esophageal reflux disease and recommended the filter not be removed as it had been in for many years and would be considered high risk.An abdominal x-ray performed approximately three years post implant to evaluate the filter, noted that filter is noted to the right of mid-line in the expected location of the ivc at l2-l3.The index procedure notes did not specify if the tip of the filter or the body of the filter was at l1, additionally the post implant x-ray does not specify the level of the body versus the tip.There is currently no additional information available.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 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 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 thrombosis within the filter do not represent a device malfunction.With time, high pressure in the leg veins due to venous insufficiency of either the superficial or deep veins (or both) can cause leakage of blood out of the capillary beds, resulting in edema of the legs.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 includes 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.Without the procedural films or post implant images to review the reported filter migration and occlusion of the ivc could not be confirmed or further clarified.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.Anxiety, chest pain, difficulty walking and leg swelling do 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.According to the patient profile form (ppf), the patient¿s medical history consists of hypertension, asthma, hypothyroidism, gastric ulcer and hyperlipidemia, previous back surgery, sleep apnea, cardiac murmur.Approximately three years and one-month post implant the patient was evaluated for angina and possible removal of the filter.The evaluation noted possible gastro-esophageal reflux disease and recommended the filter not be removed as it had been in for many years and would be considered high risk.An abdominal x-ray performed approximately three years post implant to evaluate the filter, noted that ivc filter was in satisfactory position.According to the patient profile form the filter was placed for left lower extremity dvt.The ppf indicates that the filter is embedded and can¿t be retrieved, although there are no recorded attempts to retrieve the device.The form also indicates that there are blood clots, clotting and/or occlusion of the ivc.The patient still experiences chest pain, the left leg swells and gets blood clots and the patient reports that it is hard to walk because of the pain.The patient is also reported to be suffering from mental anguish related to the device.The filter was implanted via the right internal jugular vein and deployed at the level of l1.The product remains implanted and is thus not available for analysis.A review of the manufacturing records could not be conducted without a lot number.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6882559
• MDR Text Key: 87173250
• Report Number: 1016427-2017-00598
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• 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: UNKFILTER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR