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

Model Number	466P306AU
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to migration, perforation and broken posterior side strut.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, loss of enjoyment of life and other damages.Information received per the medical records indicate that the patient has a history of bilateral acute pulmonary embolism with relative contraindication of anticoagulation.The patient was a poor candidate for long term anticoagulation as she stumbles and has an ataxic gait.The filter was implanted via the patient's right femoral vein.The tip of the sheath was placed at the level of the fourth lumbar vertebra.A vena cava gram was performed.No clots were found and the vena cava measured less than 30 mm in diameter.The sheath was repositioned so that the tip was at the level of the lowest renal vein, which was at the first lumbar vertebra.The filter was deployed with the top of the filter at the level of the lowest renal vein.The patient tolerated the procedure well.Information received per the patient profile form (ppf) states that the patient experienced filter fracture (posterior side strut), perforation of filter strut(s) outside the ivc and migration of fractured strut(s).The patient became aware of the reported events approximately five years and three months after the index procedure.The patient continues to experience worry related to the filter.
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.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.Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
As reported a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused migration, perforation and broken posterior side strut.The patient reported becoming aware of the events approximately five years and three months post implant.The patient also reported anxiety related to the filter.According to the medical records the indication for the filter implant was bilateral acute pulmonary embolism with a relative contraindication to anticoagulation due to an ataxic gate.The filter was placed via the right femoral vein and deployed with the top of the filter at the level of the lowest renal vein.The patient tolerated the procedure well.Prior to deployment a vena cava gram was performed, no clots were found, and the vena cava measured less than 30 mm in diameter.The product remains implant and therefore not available 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 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 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.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu) and notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu also 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 inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.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: TRAPEASE PVCF FEM/JUG 55CM CSI
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14260916
• Report Number: 9616099-2022-05603
• Device Sequence Number: 14878723
• Product Code: DTK
• UDI-Device Identifier: 20705032009451
• UDI-Public: 20705032009451
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17317209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/02/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LONG VENA CAVA FILTER SHEATH.; UNKNOWN DILATOR SHEATH ASSEMBLY.; UNKNOWN MICROPUNCTURE KIT.; UNKNOWN MICROPUNCTURE SHEATH.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female