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

Model Number	466P306AU
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.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 filter fracture, organ perforation and tilt.The implant procedural details, indication for filter placement and medical history have not been provided.There is currently no additional information available for review.The product remains implant and unavailable for analysis, the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.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.Ivc filter tilt has been associated with practitioner technique and 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) and notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Perforation may impact adjacent organs.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.Without post implant image reports 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.Please note that this is the initial report for this product.
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 filter fracture, organ perforation and tilt.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, pain and suffering, and other damages.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: a2, a4, b3, b4, b5, b6, b7, d1, d4, d10, g2, g3, g6, h1, h2 and h6.Additional information is pending and will be submitted within 30 days of receipt.
Event or Problem Description
Additional information received per the medical records indicate that the patient has a history of deep vein thrombosis (dvt).The filter was implanted via the patient's right internal jugular vein.It was placed into the inferior vena cava (ivc) and a venogram was performed to confirm the location of the renal veins.The filter was deployed into the infrarenal area of the ivc.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture within the ivc, ivc perforation, organ perforation and filter tilt.The patient became aware of the reported events approximately ten years and three months after the index procedure.The patient also experienced the following: pain ( leg, chest, neck, shoulder, ankle, back), hand swelling, tingling, hand cold, breathing problems, rapid heartbeat, hard heart rhythm, confusion, lightheadedness, hypotension, nausea, diverticulosis, bowel ailments, bleeding, depression and nightmares.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: b4, d4, 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 filter fracture, organ perforation and tilt.The patient reported becoming aware of filter fracture, inferior vena cava (ivc) and organ perforation, and filter tilt, approximately ten years and three months post implant.The patient also reported experiencing leg, chest, neck, shoulder, ankle and back pain, hand swelling, tingling and cold, breathing problems, rapid heartbeat, hard heart rhythm, confusion, lightheadedness, hypotension, nausea, diverticulosis, bowel ailments, bleeding, depression and nightmares.According to the medical record the patient had a history of deep vein thrombosis.The filter was implanted via the right internal jugular vein and deployed into the infrarenal area of the ivc after a venogram was performed to confirm the location of the renal veins.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.Ivc filter tilt has been associated with practitioner technique and 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) and notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Perforation may impact adjacent organs.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.Without post implant image reports the reported events could not be confirmed or further clarified.Pain, hand swelling, tingling and cold, breathing problems, rapid heartbeat, hard heart rhythm, confusion, lightheadedness, hypotension, nausea, diverticulosis, bowel ailments, bleeding, depression and nightmares do not represent a device malfunction and may be related to underlying patient specific issues or pre-existing comorbidities that have not been provided.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: 14006151
• Report Number: 9616099-2022-05517
• Device Sequence Number: 14546164
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2022

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: 09/30/2014
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15491730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 04/18/2022; 05/17/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/16/2022; 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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: COOK MICROPUNCTURE NEEDLE; UNKNOWN DILATOR; UNKNOWN MICROWIRE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 93 KG