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

Model Number	466P306X
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Perforation (2001); Perforation of Vessels (2135); Stenosis (2263)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation, tilt, and stenosis.The indication for the filter implant has not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The trapease ivc 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.Stenosis is an abnormal narrowing of a vessel and does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, 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 notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.There is nothing to suggest that the reported events are 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 or Problem Description
As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, filter perforation, tilt, 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 continue to suffer significant medical expenses, pain and suffering, and other damages.
Event or Problem Description
Additional information received per the medical records indicate that the patient had a preoperative diagnosis of deep vein thrombosis (dvt) and contraindication for anticoagulation.The patient had significant hemorrhage while on anticoagulant for very large rectal hemorrhoids.The patient needed treatment for these hemorrhoids.The patient also had bilateral lower extremity acute dvt.The filter was implanted via the patient's right femoral veins.A venogram was obtained revealing a widely patent ivc.The filter was deployed.A postprocedural venogram revealed a widely patent filter and continued patency of the renal veins.Additional information received per the patient profile form (ppf) states that the patient experienced tilt and perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported events approximately twelve years and five months after the index procedure.The patient also experienced anxiety, shortness of breath, blurry vision, dizziness, "balance is off" and unspecified issues with both legs.
Additional Manufacturer Narrative
It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation, tilt, and stenosis.The patient reported becoming aware of tilt and perforation of filter struts outside the inferior vena cava (ivc), approximately twelve years and five months post implant.The patient also reported anxiety, shortness of breath, blurry vision, dizziness, "balance is off" and unspecified issues with both legs due to the filter.According to the medical record the indication for the filter implant was deep vein thrombosis (dvt) and contraindication for anticoagulation.The patient had significant hemorrhage on anticoagulant for very large rectal hemorrhoids.The patient needed treatment for these hemorrhoids but had bilateral lower extremity acute dvt.The filter was implanted via the right femoral vein.A venogram was obtained revealing a widely patent ivc.The filter was deployed.A postprocedural venogram revealed a widely patent filter and continued patency of the renal veins.The product remains implanted and unavailable 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 ivc 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.Stenosis is an abnormal narrowing of a vessel and does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.Ivc filter tilt has been associated with practitioner technique and/or vessel anatomy, 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 notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the events has not been reported at this time and a clinical conclusion could not be determined as to the cause of the event.Without procedural films or post implant imaging available for review, the reported events could not be confirmed or further clarified.Anxiety, shortness of breath, blurry vision, dizziness, and unspecified issues with both legs do not represent a device malfunction and may be related to underlying patient specific issues or other undisclosed comorbidities.There is nothing to suggest that the reported events are 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.

• 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: 14647140
• Report Number: 9616099-2022-05701
• Device Sequence Number: 12201634
• 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: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2011
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0508393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6 FRENCH PINNACLE DESTINATION SHEATH.; BENSON WIRE.; UNKNOWN 18 GAUGE SINGLE-WALL ENTRY NEEDLE.; UNKNOWN 20 ML SYRINGE.; UNKNOWN CATHETER.; UNKNOWN OBTURATOR.; UNKNOWN.
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male