MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306AU

Device Problems Fracture (1260); Obstruction of Flow (2423); Unintended Movement (3026); Migration (4003)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Stenosis (2263)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The patient is reported to have had a history of multiple pulmonary emboli (pe) with an intolerance to coumadin therapy.The indication for the filter placement was not reported.The filter was implanted via the right femoral vein.The patient was reported to have renal veins with a high take-off and the filter was placed over the l3 vertebral body.The patient is reported to have tolerated the procedure well.Approximately nine and a half years after the filter implantation, the patient became aware that the filter had tilted and fractured with filter struts retained within the duodenal wall.The filter had also migrated and filter struts had perforated outside the inferior vena cava and into organs.In addition, the filter was associated with organ perforation and stenosis of the filter.The patient further reported having experienced swelling, pain, throbbing and itchiness of the lower extremities causing bleeding due to scratching which have contributed to lack of sleep, mobility issues and anxiety.In addition, the patient reported that the filter stenosis had caused large, lumpy veins all over the patient¿s body.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 trapease vena cava filter is indicated for use in the prevention of recurrent pe via percutaneous placement in the ivc for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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 images or procedural films for review, the reported filter tilt, fracture, migration and ivc and organ perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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 ivc 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.It is unknown if the tilt contributed to the reported perforation.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Stenosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported pain, swelling and varicose veins experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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, a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to filter fracture, organ perforation, migration, tilting and stenosis.As a direct and proximate result, 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 suffer significant medical expenses, pain and suffering and other damages.Per the implant records, the patient was reported to have a history of multiple pulmonary emboli (pe), and being intolerant of coumadin.The right groin was prepped and draped in sterile fashion, and a needle was used to access the right femoral vein.Under fluoroscopic guidance, a guidewire was threaded into the common femoral, up the iliac vein, and into the inferior vena cava.A venogram was performed, demonstrating high takeoff of the renal veins.The trapease filter was advanced and deployed over the l3 vertebral body.The patient tolerated the procedure well.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the inferior vena cava (ivc), perforation of struts into organs, tilting, stenosis and fractured filter struts retained in the duodenal wall, becoming aware of these events approximately nine years and six months after the filter implantation.The patient further asserts to have suffered from leg swelling, leg pain, throbbing and itchy legs post implant, causing bleeding due to scratching and contributing to lack of sleep, mobility issues and anxiety.Additionally, the patient reports having a non-working vena cava due to a clogged filter causing large lumpy veins all over the patient¿s body.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12307786
• MDR Text Key: 266032704
• Report Number: 1016427-2021-05276
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15379114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Date Device Manufactured: 05/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK 18-GAUGE NEEDLE, UNK GUIDEWIRE; UNK DILATOR SHEATH, UNK CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR