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

Catalog Number 466F220A

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and the event date is the complaint awareness date.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.Occupation: other, senior counsel, litigation.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, the patient underwent placement of two optease vena cava filters on the same day.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis.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, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have additional information received per the medical records indicate that the vena cava filter was placed prophylactically.The patient was also having placement of a 5-french 40 cm length profusion catheter which extended from the distal left deep femoral vein up to the proximal left common iliac vein for the intention of catheter-based direct thrombolysis.The patient had a history of extensive left leg iliofemoral vein thrombosis with secondary phlegmasia alba dolens with associated bilateral moderate pulmonary emboli.  the filter was deployed successfully via the right common femoral vein.The patient was turned over to the belly down position.There was an unsuccessful attempt to cannulate the popliteal vein.The patient was turned over again to the belly-up position.Next, there was an attempt to engage the proximal left common iliac artery with a 5-french lima catheter.The catheter got hooked on to the optease vena cava filter and the optease filter was unintentionally dragged down into the ipsilateral right common iliac vein.A 7-french 45 cm length sheath was advanced to the area and a snare catheter was used to retrieve the filter.A second inferior vena cava filter was deployed in a more optimal superior position.The lima catheter was used again, but was not providing enough support.It was exchanged for a 5-french motarjeme catheter which had better seating into the contralateral left venous iliac vein.The procedure continued with no immediate complications noted.After the procedure, the venography imaging showed complete outflow obstruction from the left iliofemoral venous system.Additional information received per the patient profile form (ppf) states that with the second device that was later implanted, the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava.The patient became aware of the reported events five years after the index procedure.The patient also experienced emotional distress, mental anguish, anxiety and stress.The ppf states that the first filter was replaced due to its placement.A later computed tomography (ct) scan discovered deep vein thrombosis present with the second device that was later implanted.Corrected data : initial report sent to fda: no, the initial reporter did not send a report to the fda.Mfr site: reporting contact facility: cordis corporation.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: date of report, pma/510k, type of reportable event and if follow-up what type.Event: as reported, the patient had placement of two optease inferior vena cava (ivc) filters on the same day.Per the medical records, the ivc filter was placed prophylactically.The patient was also had placement of a 5-french 40 cm length profusion catheter from the distal left deep femoral vein up to the proximal left common iliac vein for the intention of catheter-based direct thrombolysis.History includes extensive left leg iliofemoral vein thrombosis with secondary phlegmasia alba dolens with associated bilateral moderate pulmonary emboli.The filter was deployed successfully.There was an unsuccessful attempt to cannulate the popliteal vein.Next, there was an attempt to engage the proximal left common iliac artery with a 5-french lima catheter.The catheter got hooked on to the optease vena cava filter and the optease filter was unintentionally dragged down into the ipsilateral right common iliac vein.A 7-french 45 cm length sheath was advanced to the area and a snare catheter was used to retrieve the filter.A second inferior vena cava filter was deployed in a more optimal superior position.The lima catheter was exchanged for a 5-french motarjeme catheter.The procedure continued with no immediate complications noted.After the procedure, the venography imaging showed complete outflow obstruction from the left iliofemoral venous system.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis.Per the patient profile form (ppf), the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava.The patient also experienced emotional distress, mental anguish, anxiety and stress.The ppf states that the first filter was replaced due to its placement.A later computed tomography (ct) scan discovered deep vein thrombosis present.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 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 occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.

Manufacturer Narrative

Section h6: method code corrected to 4114.To date, a lot number has not been provided; therefore, no device analysis nor device history record review could be performed.Section b5: as reported, the patient underwent placement of two optease vena cava filters on the same day.The indication for the filter placements was not reported.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis (dvt).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, and pain and suffering, and other damages.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 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.Blood clots that develop in the veins of the leg or pelvis, may be related to a condition called dvt.Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.This event does not represent a malfunction of the device.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

As reported by the legal brief, the patient underwent placement of two optease vena cava filters on the same day.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to deep vein thrombosis.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.The medical records received indicate that the vena cava filter was placed prophylactically.The patient was also having placement of a 5-french 40 cm length profusion catheter which extended from the distal left deep femoral vein up to the proximal left common iliac vein for the intention of catheter-based direct thrombolysis.The patient had a history of extensive left leg iliofemoral vein thrombosis with secondary phlegmasia alba dolens with associated bilateral moderate pulmonary emboli.The filter was deployed successfully via the right common femoral vein.; the patient was turned over to the belly down position.There was an unsuccessful attempt to cannulate the popliteal vein; the patient was turned over again to the belly-up position.Next, there was an attempt to engage the proximal left common iliac artery with a 5-french lima catheter.The catheter got hooked on to the optease vena cava filter and the optease filter was unintentionally dragged down into the ipsilateral right common iliac vein.A 7-french 45 cm length sheath was advanced to the area and a snare catheter was used to retrieve the filter.A second inferior vena cava filter was deployed in a more optimal superior position.The lima catheter was used again, but was not providing enough support, and it was exchanged for a 5-french motarjeme catheter which had better seating into the contralateral left venous iliac vein.The procedure continued with no immediate complications noted.After the procedure, the venography imaging showed complete outflow obstruction from the left iliofemoral venous system.Per the patient profile form (ppf) the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava (ivc).The patient became aware of the reported events five years after the index procedure.The patient also experienced emotional distress, mental anguish, anxiety and stress.The ppf states that the first filter was replaced due to its placement.A later computed tomography (ct) scan discovered deep vein thrombosis present.According to the amended patient profile form (ppf) the patient additionally reports tilting and occlusion of the optease inferior vena cava filter.

Manufacturer Narrative

As reported, the patient underwent placement of two optease inferior vena cava (ivc) filters on the same day.Per the medical records, the indication was prophylactic in the face of left dvt being treated with thrombolysis.History includes extensive left leg iliofemoral vein thrombosis with secondary phlegmasia alba dolens with associated bilateral moderate pulmonary emboli.The filter was deployed successfully in an infrarenal position.There was an unsuccessful attempt to cannulate the popliteal vein.Next, there was an attempt to engage the proximal left common iliac artery with a 5-french lima catheter.The catheter got hooked on to the filter, and unintentionally dragged the filter down into the ipsilateral right common iliac vein.A 7-french 45 cm length sheath was advanced to the area and a snare catheter was used to retrieve the filter.A second inferior vena cava filter was deployed in a more optimal superior position.The procedure continued with no immediate complications noted.Post procedure imaging showed complete outflow obstruction from the left iliofemoral venous system.The report states that the filter subsequently malfunctioned including, but not limited to deep vein thrombosis (dvt).Per the patient profile form (ppf), the patient reports tilt, blood clots, clotting, and/or occlusion of the ivc and filter and anxiety.The ppf states that the first filter was replaced due to its placement.A ct scan revealed deep vein thrombosis after filter implant.Filter #1: 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.Filter #2: 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 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 procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8262142
• MDR Text Key: 133688930
• Report Number: 1016427-2019-02427
• 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,Followup,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 466F220A
• Device Lot Number: 15538438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/19/2019; 03/28/2019; 04/30/2019; 10/28/2020
• Supplement Dates FDA Received: 02/18/2019; 04/26/2019; 05/24/2019; 11/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR