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

Catalog Number R055271

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Occlusion (1984); Perforation (2001); Thrombosis (2100)

Event Date 11/03/2017

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 an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to caval thrombosis, perforation of the inferior vena cava and the device was unable to be retrieved.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.Although the brief states that the device was unable to be retrieved, there was no documented attempt to retrieve the device.

Manufacturer Narrative

Additional information received per the medical records stats that the filter was placed due to deep vein thrombosis and an abdominal wall bleed.The patient was contraindicated to anticoagulation therapy.The filter was placed via the right internal jugular vein.The filter was advanced and deployed below the level of the renal veins, there were no immediate complications.Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter strut(s) outside the inferior vena cava, blood clots, clotting, and/or occlusion of the inferior vena cava.The patient became aware of the reported events ten years after the index procedure after undergoing a computed tomography scan.The form also states that the device was unable to be retrieved. there was an unsuccessful attempt to remove the device approximately one month after the index procedure.The patient also experienced pain and swelling of the lower extremities, primarily the left and cannot walk more than approximately 50 feet without experiencing shortness of breath, in addition to anxiety.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

Section b5: it was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter perforated, there was retrieval difficulty with an unsuccessful attempt to remove the filter, the patient experienced blood clots, clotting, and/or occlusion of the inferior vena cava.The patient also experienced pain and swelling of the lower extremities, primarily the left and cannot walk more than approximately 50 feet without experiencing shortness of breath, in addition to anxiety.The indication for the filter implant was deep vein thrombosis and an abdominal wall bleed and therefore a contraindication to anticoagulation.The filter was placed via the right internal jugular vein and deployed below the level of the renal veins, with no immediate complications.Approximately twenty-two days later the patient underwent an unsuccessful percutaneous attempt to retrieve the filter.The procedural details of the explant attempt have not been provided.The patient became aware of the reported events ten years after the index procedure after undergoing a computed tomography scan.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number provided is invalid; 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, making subsequent removal attempts difficult.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.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.It was reported that there was perforation of the ivc.A review of the instructions for use notes vessel damage such as intimal tears and perforation as a long-term and a procedural complication associated with ivc filters.Without the procedural films or post implant images to review the reported, perforation and thrombosis could not be confirmed or further clarified.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.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 swelling and discomfort or pain of the affected extremity.Anxiety, shortness of breath (dyspnea) and difficulty walking related to dyspnea do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to determine what may have contributed to the reported events.There is nothing in the limited information provided 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.Section d4: the lot number provided is invalid and the catalog number is unknown.Section d6: the correct implant date was provided in the medical records.The correct date is (b)(6) 2017.Section h6: method: an analysis of production records could not be conducted as the lot number provided is invalid.

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 injury and damage to the patient including, but not limited to caval thrombosis, perforation of the inferior vena cava and the device was unable to be retrieved, although an attempt to retrieve the device has not been documented.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.There is currently no additional information available for review.The product was not returned for analysis and the sterile lot number provided is invalid; 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.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.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as a long-term and a procedural complication associated with ivc filters.Without the procedural films or post implant images to review the reported, perforation and thrombosis could not be confirmed or further clarified.With the limited information provided it is not possible to determine what may have contributed to the reported events.There is nothing in the limited information provided 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: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8260926
• MDR Text Key: 133531710
• Report Number: 1016427-2019-02423
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R055271
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.035 J WIRE; UNKNOWN 5 FR SHEATH; UNKNOWN 5 FRENCH PIGTAIL CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 69 YR