MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; VENA CAVA FILTER

Model Number N/A

Device Problems Difficult to Remove (1528); Failure to Align (2522); Unintended Movement (3026)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135)

Event Date 12/11/2012

Event Type  Injury  

Manufacturer Narrative

The product remains implanted and is thus not available for analysis.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported in the legal brief, plaintiff (b)(6) is domiciled and resides in the state of (b)(6).(b)(6) underwent placement of an optease filter in the state of (b)(6).The device, inter alia, tilted, migrated and perforated his vena cava.As a result of these malfunctions, he suffered and will continue to suffer life-threatening injuries and damages and required extensive medical care and treatment, including multiple medical procedures.Plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses.

Manufacturer Narrative

As reported in the legal brief, a patient underwent placement of an optease filter.The device, inter alia, tilted, migrated and perforated his vena cava.As a result of these malfunctions, the patient suffered and will continue to suffer life-threatening injuries and damages and required extensive medical care and treatment, including multiple medical procedures.The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, disability, and other losses.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.  without images or procedural films for review, the reported filter tilt and migration could not be confirmed and the exact cause could not be determined.Giving the limited information available at this time, clinical factor contributing to the migration could not be determined.Inferior vena cava (ivc) filter migration 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 migration includes 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.Additionally, the timing and mechanism of the reported tilt could not be determined.Vessel perforation was also reported but could not be confirmed.The instructions for use note vessel injury as a potential complication of filter implantation.However, 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 following additional information received per the patient profile form (ppf) indicates that the filter perforated into the organs, was embedded in the ivc and was unable to be retrieved.Per the medical records, the filter was noted to be slightly angulated during the removal procedure.The patient underwent the unsuccessful attempt to remove the filter ten months and twenty-four days post implantation.The patient is also suffering from distress, daily fear and anxiety.According to the information received in the medical records, the patient was admitted with deep vein thrombosis (dvt) prior to the filter placement.The indication for the filter implantation procedure was pulmonary embolus (pe) and contraindication to anticoagulation.The filter was deployed below the renal veins.The patient tolerated the procedure well and had no immediate complications.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of a optease inferior vena cava (ivc) filter.The information provided indicated that the device, inter alia, tilted, migrated and perforated the vena cava.It was also noted that the filter perforated into the organs, was embedded in the ivc and was unable to be retrieved.Per the medical records, the filter was noted to be slightly angulated during the removal procedure.The patient underwent the unsuccessful attempt to remove the filter ten months and twenty-four days post implantation.The patient is also experiencing from distress, daily fear and anxiety.The indication for the filter implantation procedure was pulmonary embolus (pe) and contraindication to anticoagulation.The filter was place via the right internal jugular vein and deployed below the renal veins that entered the ivc at approximately the l1-l2 disk space.The patient tolerated the procedure well and had no immediate complications.Approximately eleven months later, as a request, an attempt was made through the right groin to remove the filter.Multiple attempts were made to capture the hook of the filter with a snare device, these were ultimately unsuccessful.Access was then obtained from the left common femoral vein.Multiple attempts were made to snare the filter through this approach but were ultimately unsuccessful.Additional intervention included using a 10mm by 4cm low pressure balloon from the right side in order to push on the filter, this was also unsuccessful.The procedure was discontinued and there were no reported immediate complications.The procedure notes the impression as that of unsuccessful attempt at removal of ivc filter secondary to the hook being up against a wall, although not well documented on venography.There is currently no additional information available.The product was not returned for analysis and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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 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 reported event notes that the first attempt to remove the filter took place approximately eleven months after the index procedure.Retrieval of the optease vena cava filter is indicated 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.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it 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 instruction for use (ifu) as such.Possible causes for filter migration includes 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 the procedural films or post implant images to review the reported, tilt, migration and perforation 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 device malfunction and may be related to underlying patient specific issues.Given the limited information provided 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.

• Brand Name: 466FXXXX
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6199856
• MDR Text Key: 63176356
• Report Number: 1016427-2016-00138
• 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
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466FXXXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/05/2016
• Date Manufacturer Received: 04/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN 5 FRENCH MICRO PUNCTURE; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 145