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

Catalog Number 466FXXXX

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease vena cava filter.Approximately ten years post implantation the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient including but not limited to, at least six struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care 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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.An 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.The legal briefing mentioned a perforation of the ivc wall.Without procedural films available for review, the reported perforation could not be confirmed.With the information available it is not possible to draw a clinical conclusion to the reported event, and the exact cause could not be determined.The instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Also, with 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 brief, the patient underwent placement of defendants optease vena cava filter approximately ten years post implantation the patient underwent an updated ct scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient including but not limited to, at least six struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of coronary artery disease, pulmonary embolism, chest pain and an acute myocardial infarction.It was noted that the patient had a pulmonary embolectomy three days prior to insertion of this device.The vena cava filter was deployed below the level of the renal veins.The filter was in a good position with good alignment.After the procedure, the patient was in stable condition.According to the patient profile form (ppf) one to two months after placement of the filter, an unsuccessful attempt was made to retrieve the device.The patient continues to experience depression, fear and anxiety.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.It was reported that a patient underwent placement of a optease vena cava filter.The information provided indicated that the patient underwent an updated computed tomography (ct) scan approximately ten yeas post implant of the filter.The scan report indicates that the filter malfunctioned and caused injury and damages to the patient including but not limited to, at least six struts were significantly perforating the inferior vena cava (ivc).The information provided also indicated that there was a failed open abdominal retrieval attempt one to two months after the initial implant.The patient is also reported to experience depression, fear and anxiety related to the device.The indication for the device implant was pulmonary embolism status post coronary artery bypass surgery (cabg).Eight days prior to the implant the patient was admitted with chest pain and was found to have an acute myocardial infraction (mi).Imaging was performed, and the patient ultimately had a cabg.The patient subsequently developed bilateral pe which required pulmonary embolectomy which was performed four days after the cabg.Vascular surgery has requested an ivc implant as the patient cannot tolerate full anticoagulation due to two chest surgeries.The filter was implanted via the right common femoral vein and deployed below the level of the renal veins and above the bifurcation without any difficulties.There is currently no additional information available.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.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.The timing and mechanism of the retrieval difficulty and perforation has not been reported at this time and 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 procedural complications related it ivc filters.Without the procedural films or post implant images to review the reported, perforation and retrieval difficulty could not be confirmed or further clarified.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.Anxiety does not represent a malfunction and may be related to patient specific underlying 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:date of report, pma/510k, type of reportable event and if follow-up, what type.Correction: section event: as reported, the patient underwent placement of an optease vena cava filter.Approximately ten years post implantation, the patient underwent an updated computed tomography (ct) scan which revealed that the filter had subsequently malfunctioned and caused injury and damages to the patient including but not limited to, at least six struts were significantly perforating the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered and continues to suffer life-threatening injuries and damages, which required and will continue to require extensive medical care treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.Additional information received per the medical records indicate that the patient has a history of coronary artery disease, pulmonary embolism, chest pain and an acute myocardial infarction.It was noted that the patient had a pulmonary embolectomy three days prior to insertion of this device.The vena cava filter was deployed below the level of the renal veins.The filter was in a good position with good alignment.After the procedure, the patient was in stable condition.According to the patient profile form (ppf) one to two months after placement of the filter, an unsuccessful attempt was made to retrieve the device.The patient continues to experience depression, fear and anxiety related to this device.The product was not returned for analysis.The dhr could not be completed.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.The timing and mechanism of the retrieval difficulty and perforation has not been reported at this time and 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 procedural complications related it ivc filters.Without the procedural films or post implant images to review the reported, perforation and retrieval difficulty could not be confirmed or further clarified.Clinical factors that may have influenced these events include patient, pharmacological and lesion characteristics.Anxiety does not represent a malfunction and may be related to patient specific underlying 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: b4, b5, g4, g7, h1, h2 and h6.It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter perforated the inferior vena cava (ivc) and abuts an organ, tilted and there was a failed retrieval attempt.The patient underwent an updated computed tomography (ct) scan approximately ten yeas post implant of the filter, which noted that there were at least six struts significantly perforating the inferior vena cava (ivc).The information provided also indicated that there was a failed open abdominal retrieval attempt one to two months after the initial implant.The patient is also reported to experience depression, fear and anxiety related to the device.The indication for the device implant was pulmonary embolism status post coronary artery bypass surgery (cabg).Eight days prior to the implant the patient was admitted with chest pain and was found to have an acute myocardial infraction (mi).Imaging was performed, and the patient ultimately had a cabg.The patient subsequently developed bilateral pe which required pulmonary embolectomy and was performed four days after the cabg.Vascular surgery had requested an ivc implant as the patient could not tolerate full anticoagulation due to two chest surgeries.The filter was implanted via the right common femoral vein and deployed below the level of the renal veins and above the bifurcation without any difficulties.Additional information provided indicated that the patient became aware of filter tilt and perforated struts abut an organ approximately two years post implant.There is currently no additional information available.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.Ivc filter tilt has been associated with the anatomy of the vessel, 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.It is unknown if the tilt contributed to the reported perforation.Without images available for review the reported events could not be confirmed or further clarified.Anxiety does not represent a malfunction and may be related to patient specific underlying 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

In addition to the previously reported events, an amended patient profile form (ppf) states that the patient also experienced tilting of the filter and it noted that the perforation abuts an organ.The patient became aware of the reported events two years after the index procedure.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7142001
• MDR Text Key: 95609431
• Report Number: 1016427-2017-00892
• 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,Followup,Followup,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN DILATOR; UNKNOWN GUIDE WIRE; UNKNOWN SHEATH; UNKNOWN INTRODUCER; UNKNOWN NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 49 YR