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

Model Number 466FXXXX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Abrasion (1689); Coagulation Disorder (1779); Edema (1820); Embolus (1830); Occlusion (1984); Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263); Ulcer (2274); Thrombosis/Thrombus (4440)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

As reported by the legal team, the patient underwent placement of the optease filter on or about (b)(6) 2013 in (b)(6).The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, dvts, pulmonary emboli, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound.As a direct and proximate result of these malfunctions; the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.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.Thrombosis, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound does not represent a device malfunction.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.

Event Description

As reported by the legal team, the patient underwent placement of the optease filter on or about (b)(6) 2013 in tennessee.The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, dvts, pulmonary emboli, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound.As a direct and proximate result of these malfunctions; the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

Product name optease retrieval filter.Product catalog number 466f220a lot number 15781096.According to the additional information received in the patient profile form (ppf), additional information provided on the patient profile form (ppf) indicated that the patient became aware approximately three years and five months post filter implant that there were blood clots, clotting and/or occlusion of the inferior vena cava (ivc) filter.The ppf also indicated that the patient has suffered from mental anguish, continuing clots and swelling of the legs.According to the medical records the filter was implanted for recurrent dvt and non-compliance with coumadin, in addition, the patient incurred a fracture to the left ankle and awaits surgical repair.The filter was implanted via the right femoral vein and deployed at the location of the third lumbar vertebral body.The patient tolerated the procedure well.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.

Manufacturer Narrative

Complaint conclusion: as reported by the legal team, the patient underwent placement of the optease filter on or about (b)(6) 2013 in (b)(6).The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, dvts, pulmonary emboli, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound.As a direct and proximate result of these malfunctions; the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.The device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Without the return of the device for analysis and without films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.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.Thrombosis, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound does not represent a device malfunction.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

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.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, resulting in swelling/edema/bulging of the effected extremity(s).Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Blood clots, clotting and/or occlusion of the ivc do not represent a device malfunction.Without the procedural films or post-placement imaging and the limited information provided, the report of blood clots, clotting and occlusion of the inferior vena cava (ivc) filter could not be confirmed or clarified, nor can a conclusion about a relationship between the reported events and the filter be drawn.Anxiety, stasis ulcers, bilateral lower extremity edema and a chronic open leg wound do not represent a device malfunction and may be related to underlying patient specific issues and/or pre-existing conditions.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal team, the patient underwent placement of the optease filter.The filter subsequently malfunctioned and caused injuries and damages to the patient, including, but not limited to, deep vein thrombosis (dvts), pulmonary emboli, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound.As a direct and proximate result of these malfunctions; the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.Additional information provided on the patient profile form (ppf) indicated that the patient became aware approximately three years and five months post filter implant that there were blood clots, clotting and/or occlusion of the inferior vena cava (ivc).The ppf also indicated that the patient has suffered from mental anguish, continuing clots and swelling of the legs.According to the medical records the filter was implanted for recurrent dvt and non-compliance with coumadin, in addition, the patient incurred a fracture to the left ankle and awaits surgical repair.The filter was implanted via the right femoral vein and deployed at the location of the third lumbar vertebral body.The patient tolerated the procedure well.According to the information received in the redacted patient profile form (ppf), the patient additionally reports becoming aware of perforation of filter struts outside the ivc, perforation of filter struts into organs, filter tilting and migration, stenosis, and caval thrombosis, becoming aware of these events approximately three years and three months after the filter implantation, and further experienced ongoing clots, swelling of the legs and a right leg dvt related to the filter.

Manufacturer Narrative

It was reported that a patient underwent placement of the optease filter.The information provided indicated that the filter subsequently malfunctioned and caused, deep vein thrombosis (dvts), pulmonary emboli, stasis ulcers, bilateral lower extremity edema, and a chronic open leg wound.The patient reported becoming aware of blood clots, clotting and/or occlusion of the inferior vena cava (ivc) approximately three years and five months post implant.The patient also reported mental anguish, continuing clots and swelling of the legs.According to the medical records the filter was implanted for recurrent dvt and non-compliance with coumadin, in addition, the patient incurred a fracture to the left ankle and awaits surgical repair.The filter was implanted via the right femoral vein and deployed at the location of the third lumbar vertebral body.The patient tolerated the procedure well.Additional information provided by the patient the patient became aware of indicated that there was perforation of filter struts outside the ivc, perforation of filter struts into organs, filter tilting and migration, stenosis, and caval thrombosis, approximately three years and three months post implant.The patient further experienced ongoing clots, swelling of the legs and a right leg dvt related to the filter.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 that develop in the veins of the leg or pelvis, may be related to a condition called deep vein thrombosis (dvt).Large thrombus within the vena cava or lower extremities may impede perfusion and cause venous insufficiency, resulting in swelling/edema/bulging of the effected extremity(s).Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.Clinical factors that may have influenced the events include patient, pharmacological and lesion characteristics.Blood clots, clotting and/or occlusion of the ivc, stenosis, and thrombosis do not represent a device malfunction.Without the procedural films or post-placement imaging and the limited information provided, the report of blood clots, clotting and occlusion of the inferior vena cava (ivc) filter could not be confirmed or clarified, nor can a conclusion about a relationship between the reported events and the filter be drawn.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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the 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.Without images available for review the reported events could not be confirmed or further clarified.Anxiety, stasis ulcers, bilateral lower extremity edema and a chronic open leg wound do not represent a device malfunction and may be related to underlying patient specific issues and/or pre-existing conditions.There is nothing in the reported information to suggest that there is a design or manufacturing related issue, as such no corrective action will be taken.Should additional information become available, the file will be updated.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 6791582
• MDR Text Key: 82600825
• Report Number: 1016427-2017-00534
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: 15781096
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/31/2017
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK CATHETER; UNK NEEDLE, UNK GLIDEWIRE; UNK WIRE, UNK 8FCATHETER; UNKNOWN TISSUE UNKNOWN NEEDLE UNKNOWN GLIDEWIRE UN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 50 YR