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

Model Number	466P306X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Perforation of Vessels (2135)
Date of Event	03/29/2021
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 abutting adjacent organs.The indication for the filter implant, procedural details and patient medical history has not been provided.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 trapease ivc filter is indicated for permanent placement.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).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant imaging available for review, the reported event could not be confirmed or further clarified.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.
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, malfunction including perforation abutting adjacent organs.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
The filter was implanted via a right side femoral approach.An inferior vena cavogram was done showing no vena cava thrombus.The sheath was then maneuvered to the l1-l2 disc space level.The filter was placed at this level with the bulk of the filter over the l2 vertebral body.Following the procedure, the sheath and cannula were removed.Hemostasis was achieved and the patient returned to their room in unchanged condition.Additional information received per the patient profile form (ppf) states that the patient experienced perforation abutting organs.The patient became aware of the reported event approximately sixteen years after the index procedure.The patient reported that they experienced worry, anxiety related to the filter perforating outside the vena cava and abutting adjacent organs.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: a2, b2, b3, b4, b5, d1, d4, d10, e2, g2, g3, g6, h1, h2, h4 and h6.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 abutting adjacent organs.The patient reported becoming aware of the event approximately sixteen years post implant.The patient also reported anxiety related to the filter.The indication for the filter placement was not documented.The filter was placed via the right femoral approach and deployed at the l1-l2 disk space level.A pre-deployment inferior vena cavogram was done showing no vena cava thrombus.The patient returned to their room in unchanged condition.The product remains implanted 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 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 trapease ivc filter is indicated for permanent placement.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).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant imaging available for review, the reported event could not be confirmed or further clarified.Anxiety is an emotion characterized by an unpleasant state of inner turmoil, often accompanied by nervous behavior, somatic complaints, and rumination.The physiological symptoms of anxiety may include, but are not limited to neurological, respiratory, cardiac, muscular, and cutaneous.These symptoms of anxiety do not represent a device malfunction and may be related to underlying patient specific issues.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.Section e2 - correct response is no.

• Brand Name: TRAPEASE PVCF FEM/JUG 55 CMCSI
• 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: 14453460
• Report Number: 9616099-2022-05645
• Device Sequence Number: 6340400
• 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: 2005
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: 11/30/2007
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1204333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2004
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6 FRENCH TRAPEZE COMBINATION CATHETER AND PLACEMEN; UNKNOWN CANNULA
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 49 YR
• Patient Sex: Male