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

Model Number 466P306AU

Device Problem Fracture (1260)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter 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.The indication for the filter placement, procedural details and medical history have not been provided and there is 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.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.The timing and mechanism of the reported event 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 filter fracture 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.Please note that this is the initial report for this product.

Event 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.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.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b6, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.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.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

Additional information received per the medical records state that after right knee surgery the patient developed bilateral pulmonary emboli.The patient began lovenox and subsequently developed a right hepatic hematoma.The anticoagulation treatment was discontinued.It was determined that the filter would be implanted prophylactically and embolization of the hepatic bleeding site would be done.The filter was implanted via the patient's right internal jugular vein (ijv).Access to the ijv was performed and an 0.018 wire was passed centrally.A 5 french micropuncture sheath was placed.Then an amplatz wire was advanced into the cava.A 6 french sheath was advanced into the inferior vena cava (ivc).An co2 venocavogram was performed and then the filter was delivered into the infrarenal area of the ivc.A post procedural venocavogram demonstrated satisfactory caval coverage.Next, a flow directed gel foam embolization procedure was conducted.The patient tolerated the procedure without difficulty.The patient reported immediate improvement in their pain following the embolization and was transferred to intensive care unit (icu) in stable condition.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture.The patient became aware of the reported events approximately sixteen years and three months after the index procedure.The patient also experienced anxiety related to the filter.

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 filter fracture.The patient reported becoming aware of the event approximately sixteen years and three months post implant.The patient also experienced anxiety related to the filter.According to the medical records, the indication for the filter placement was deep vein thrombosis prophylaxis after developing bilateral pulmonary emboli status post right knee surgery with the development of a hepatic hematoma while on lovenox and requiring embolization of the hepatic bleeding site.The filter was placed via the right internal jugular vein and deployed in the infrarenal ivc.Next, a flow directed gel foam embolization procedure was conducted.The patient tolerated the procedure without difficulty.The patient reported immediate improvement in their pain following the embolization and was transferred to intensive care unit (icu) in stable condition.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 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.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.The timing and mechanism of the reported 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 fracture and perforation 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.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: 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: 13599213
• MDR Text Key: 286129826
• Report Number: 9616099-2022-05372
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2007
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0204767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 04/08/2022; 05/04/2022
• Supplement Dates FDA Received: 05/04/2022; 05/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN 0.018 WIRE; UNKNOWN 5 FRENCH MICROPUNCTURE SHEATH; UNKNOWN 6 FRENCH SHEATH; UNKNOWN AMPLATZ WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female