MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/20/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.Occupation: other, senior counsel, litigation.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.Additional information is pending and will be submitted within 30 days of receipt.

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 fracture of the filter and embedment of the filter struts.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, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: date of report, pma/510k, type of reportable event, if follow-up what type.Event: as reported, the patient had placement of a trapease inferior vena cava (ivc) filter.Per the medical records, history includes super morbid obesity with venous insufficiency, chronic venous stasis disease.The filter was implanted prophylactically prior to gastric bypass surgery with high risk for deep vein thrombosis and pulmonary embolism.The filter was placed inferior to the junction of the renal veins.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to fracture of the filter and embedment of the filter struts.Per the medical records, twelve years and nine months after the index procedure the patient underwent a complex procedure to explant the filter.The procedure required loop snare, forceps and laser sheath techniques.After several attempts to remove the filter, it fractured.The majority of the device was drawn into the sheath and removed from the body.Forceps were used to remove several additional fragments.A single filter fragment remained embedded in the posterior wall of the inferior vena cava (ivc) with no portion of the fragment within in the lumen of the vessel.The procedure was stopped, the patient tolerated the removal procedure well without evidence of any immediate post procedural complications.Per the patient profile form (ppf), a ct scan approximately twelve years and one month after the index procedure indicate that the filter had multiple fractures.The filter was removed from the patient twelve years and nine months after the index procedure.There is still one fragment of the filter in the patient, embedded into the wall of the inferior vena cava.The patient has also experienced emotional distress, mental anguish, anxiety and stress.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.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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.The instructions for use (ifu) states filter fracture with separation 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 procedural films for review, the reported embedded in ivc wall and retrieval difficulty could not be confirmed and the exact cause could not be determined.Retrieval of the optease vena cava filter is indicated, in the us, up to 14 days post implantation.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to fracture of the filter and embedment of the filter struts.The filter remains implanted; thus, unavailable for analysis.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 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 pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism 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 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 predominant concern for embedding with in the wall of the ivc is the development of endothelialization.Endothelialization is the the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.Endothelialization has been shown to occur in as short a period as 12 days.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of super morbid obesity with venous insufficiency, chronic venous stasis disease.The filter was implanted prophylactically prior to gastric bypass surgery with high risk for deep vein thrombosis and pulmonary embolism.The filter was deployed via the right femoral vein.The filter was placed inferior to the junction of the renal veins.The medical records revealed that twelve years and nine months after the index procedure the patient underwent a complex procedure to explant the filter.The procedure required loop snare, forceps and laser sheath techniques.After several attempts to remove the filter, it fractured.The majority of the device was drawn into the sheath and removed from the body.Forceps were used to remove several additional fragments.A single filter fragment remained embedded in the posterior wall of the inferior vena cava (ivc) with no portion of the fragment within in the lumen of the vessel.The procedure was stopped, the patient tolerated the removal procedure well without evidence of any immediate post procedural complications.Additional information received per the patient profile form (ppf) states that computed tomography (ct) scans done approximately twelve years and one month after the index procedure indicate that the filter had multiple fractures.The filter was removed from the patient twelve years and nine months after the index procedure.There is still one fragment of the filter in the patient, embedded into the wall of the inferior vena cava.The patient has also experienced emotional distress, mental anguish, anxiety and stress.Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8161325
• MDR Text Key: 130266667
• Report Number: 1016427-2018-02357
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2007
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0704131
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 12/14/2018; 03/28/2019; 04/26/2019
• Supplement Dates FDA Received: 01/10/2019; 04/24/2019; 05/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 46 YR