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

Catalog Number 466FXXXX

Device Problems Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Code Available (3191)

Event Date 03/26/2009

Event Type  Injury  

Manufacturer Narrative

Implant date on or about (b)(6) 2009.As reported, the patient underwent placement of an optease vena cava filter.Approximately seven years post index procedure the patient was informed that his filter has subsequently malfunctioned and cause injury and damages to the patient, including, but not limited to, the filter was embedded in the wall of the inferior vena cava (ivc) and could not be removed.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 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 product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The optease 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 event description states that the patient was informed seven years after implantation that the device was embedded.Retrieval of the optease vena cava filter is indicated up to 23 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.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 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 seven years post index procedure the patient was informed that his filter has subsequently malfunctioned and cause injury and damages to the patient, including, but not limited to, the filter was embedded in the wall of the inferior vena cava (ivc) and could not be removed.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 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.

Manufacturer Narrative

Complaint conclusion being updated with new information received: codes of retrieval difficulty - unable to retrieve from vessel wall, inaccurate placement - upside down (optease only), anxiety, and vena cava injury as reported, the patient underwent placement of an optease inferior vena cava (ivc) filter.Per the medical records, the patient has a history of deep vein thrombosis, pulmonary embolism, chest pain and severe osteoarthritis with a surgical plan for bilateral knee replacements.During the implant procedure, the filter was positioned in the inferior vena cava and then deployed without difficulty.The filter had a normal fluoroscopic appearance post deployment.Approximately seven years post index procedure the patient was informed that his filter has subsequently malfunctioned and cause injury and damages to the patient, including, but not limited to, the filter was embedded in the wall of the inferior vena cava (ivc) and could not be removed.Per the patient profile from (ppf), the filter is unable to be retrieved and is backwards in vein.An unsuccessful percutaneous removal attempt was performed one month and twenty-five days post implantation.The patient reports damage to the vena cava, long term blood thinners and is fear.During the filter retrieval attempt, a venocavagram was performed and the filter appeared normal without evidence of ivc thrombus.There was neointimal hyperplasia over the strut of the filter.Attempts were made to retrieve the filter after placement of a 10-french sheath.The hook of the filter could not be snared.It was noticed that the filter appeared to be in a posterior position and could not be accessed with the snare devices.The decision was made to leave the filter in place.The filter remains implanted; thus, unavailable for analysis.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 reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Inferior vena cava (ivc) filter inaccurate placement 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 misplacement 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.Injury to the vena cava is a known potential adverse event associated with the use of the ivc filters and is listed in the ifu.Intravascular manipulation and placement of devices carries the potential to damage or perforate the vascular structures.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: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7454265
• MDR Text Key: 106283236
• Report Number: 1016427-2018-01421
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10-FRENCH SHEATH; 5-FRENCH CATHETER; 6-FRENCH INTRODUCER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR