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

Model Number 466P306X

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Coagulation Disorder (1779); Occlusion (1984); Perforation of Vessels (2135); Bowel Perforation (2668)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

This report is a follow up report to mfr number 9616099-2016-00589 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.Complaint conclusion: it was reported that a patient underwent placement of the trapease vena cava filter.According to the information received the filter subsequently malfunctioned, and was found to have embedded in the wall of the (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, and pain and suffering, and other damages.¿ additional information received per the medical records, indicated that the patient tolerated the procedure well.The patient was said to have experienced blood clots, clotting, and/or occlusion of the ivc, and that the device unable to be retrieved.The filter is said to be clogged post implantation.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 reported ¿filter embedded in wall of the ivc¿, could not be confirmed and could not be further clarified at this time.Blood clots and thrombosis/occlusion within ivc does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.The information also indicated that the filter was embedded in the wall of the ivc.Endothelialization, remodeling/restructuring of the vessel wall following device implantation, is the body¿s natural response and has been shown to occur in as short a period as 12 days.Without the procedural films to review, retrieval difficulty and adhesion to the vessel wall could not be confirmed.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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 department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned, and was found to have embedded in the wall of the (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, and pain and suffering, and other damages.Additional information received per the medical records, indicated that the patient tolerated the procedure well.The patient was said to have experienced blood clots, clotting, and/or occlusion of the ivc, and that the device unable to be retrieved.The filter is said to be clogged post implantation.

Manufacturer Narrative

Additional information included manufacturing and expiration date of the device.

Manufacturer Narrative

As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.Per the medical records, the patient tolerated the procedure well.The filter subsequently malfunctioned and was found to have embedded in the wall of the ivc, perforation of the ivc wall and organ bowel, strut fracture, fear, and migration.The patient reported blood clots, clotting, and/or occlusion of the ivc, the device unable to be retrieved, and clogged post implantation.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 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.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.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 and surrounding structures; 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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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.

• 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: 7040535
• MDR Text Key: 92313248
• Report Number: 1016427-2017-00749
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15317388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 83 YR