MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306AU

Device Problem Fracture (1260)

Patient Problems Calcium Deposits/Calcification (1758); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263)

Event Date 10/23/2018

Event Type  Injury  

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 filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to filter fracture, perforation and stenosis of the inferior vena cava (ivc).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 with perforation 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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural complications related it ivc filters.Stenosis of the ivc is associated with all ivc filter products and does not represent a device malfunction.A protective inferior vena cava (ivc) filter may later be incorporated into a chronic post-thrombotic ilio-caval obstruction (occlusive, requiring recanalization, or nonocclusive).Obstruction of varying types of ivc filters may occur due to primary thrombosis of the filter or capture of large emboli.Permanent ivc filters have been reported to obstruct in up to 20% of patients.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.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to filter fracture, perforation and stenosis of the inferior vena cava (ivc).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

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including but not limited to filter fracture, perforation and stenosis of the inferior vena cava (ivc).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.According to the information received in the patient profile from (ppf), the patient became aware of the reported events three years and eight months post implant.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of filter strut(s) outside the ivc, and fracture.There is specific evidence that the filter's dorsal struts are broken and displaced into the ivc lumen.There is also specific evidence showing all the filter struts and caudal tip pierce through the ivc walls.As a direct and proximate result of these malfunctions, the patient has 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 anxiety and mental anguish, pain in her lower back and abdomen, as well as significant past and future medical expenses.The following additional information received per the medical records state that the patient has a history of gross hematuria.A ct scan of the patient¿s abdomen was performed three years and eight months post implant.There was marked stenosis of the ivc distal to the filter.The dorsal most strut was broken and displaced into the ivc lumen.All the filter struts and the caudal tip appear to pierce through the ivc walls.Scattered vascular calcifications were noted.A cyst within the left hepatic lobe was noted.

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 injury by fracturing, perforation and stenosis the inferior vena cava (ivc).According to the patient profile from, the patient became aware of the reported events three years and eight months post implant.There is specific evidence that the filter's dorsal struts are broken and displaced into the ivc lumen and all the filter struts and caudal tip pierce through the ivc walls.The patient also reports experiencing anxiety, mental anguish and pain in the lower back and abdomen.The indication for the filter placement and procedural details have not been provided.Approximately twenty-one days post implant the patient underwent a computed tomography (ct) scan for gross hematuria.The results of the scan noted multiple small punctate submillimeter low densities within the cortex of both kidneys most consistent with very small cysts, no solid mass or obstruction was observed and no evidence of nephrolithiasis.The exam demonstrated a stable left hepatic lobe cyst, the remainder of the report was not provided.Approximately three years and eight months post implant the patient underwent a ct scan for evaluation of the filter.The findings of the scan noted that the cranial tip of the filter is fairly midline, there is marked stenosis of the ivc distal to the filter, the dorsal most strut is broken and displaced into the ivc lumen, all the filter struts and the caudal tip appear to pierce through the ivc walls.There is currently no additional information available for review.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.Without images or procedural films for review, the reported ivc stenosis, filter perforation and fracture could not be confirmed, and the exact causes could not be determined.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 complications related to ivc filters.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.Due to the nature of the complaint, the reported pain experienced by the patient could not be confirmed and the exact cause could not be determined.Pain and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.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: UNKNOWN TRAPEASE FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8641742
• MDR Text Key: 146106340
• Report Number: 1016427-2019-02899
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17156175
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 77 YR