MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466P306X

Device Problem Failure to Align (2522)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Calcium Deposits/Calcification (1758); Coagulation Disorder (1779); Occlusion (1984); Perforation (2001); Perforation of Vessels (2135)

Event Date 09/01/2004

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter had tilted and was associated with perforation.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 inferior vena cava (ivc) 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.Without images or procedural films for review, the reported filter tilt and perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 in the legal brief, a 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, physical and emotional damages from tilting and perforation of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.

Event Description

As reported in the legal brief, a 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, physical and emotional damages from tilting and perforation of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.Per the medical records provided, approximately fifteen years and ten months after the filter was implanted, the patient underwent an abdominal computed tomography (ct) scan indicated for filter evaluation.The report findings noted a trapease-shaped inferior vena cava filter with the filter axis tilted to the right by eight degrees in the coronal plane.Six peripheral struts were visualized tenting the inferior vena cava wall (grade 1 perforation), and a faint small central calcification was noticed in the filter.Also noticed, a prominent surgical clip adjacent to the posterior aspect of the upper inferior vena cava.Other incidental findings included a small cyst in the right anterior liver dome; a distended gallbladder filled with gallstones and sludge material; the right kidney surgically absent; moderate calcified atherosclerotic plaques in the lower aorta and significant degenerative disk disease at t12-l1 with osteosclerosis of the margins and anterior spurs.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately fifteen years and ten months post implantation.The patient reports filter tilting and abutting against the inferior vena cava (ivc) wall.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease vena cava filter.The indication for the filter placement was not reported.Approximately fifteen years and ten months after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that the filter was tilted to the right by eight-degrees and was abutting against the inferior vena cava (ivc).Six struts were noted to have tented within the ivc with a grade 1 perforation and with a faint small central calcification was noticed in the filter.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 ivc 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.Without images or procedural films for review, the reported filter tilt and ivc perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Calcification is the accumulation of calcium salts in a body tissue.It is transported through the blood stream.Calcification normally occurs in the formation of bone, but calcium can be deposited abnormally in any part of the body, causing it to harden.Calcification within a patient does not represent a device malfunction.Due to the nature of the complaint, the reported atherosclerotic plaque experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 vena cava filter.The indication for the filter placement was not reported.More than fifteen and a half years after the filter implantation, the patient underwent a computerized tomography (ct) scan that revealed that the filter had tilted to the right by eight degrees.Six of the filter struts were associated with a grade 1 perforation and a faint small central calcification within the filter.The patient also reported that the filter was associated with fracture, migration of fractured struts and retention of fractured strut segments; although the ct scan revealed no findings of migration or fractured fragments.The patient also reported having experienced filter embedment, blood clots, clotting and/or occlusion of the inferior vena cava (ivc).In addition, the patient indicated that the filter could not be retrieved; though attempts to retrieve it were not documented.The patient further reported having experienced shortness of breath (rendering the patient unconscious), increased respiratory rate, heart rate and blood pressure and anxiety associated with the filter.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 ivc 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.Without images or procedural films for review, the reported filter tilt, ivc perforation and device embedment events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.The predominant concern for embedding within 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.The trapease vena cava filter is designed for permanent implantation.Endothelialization has been shown to occur in as short a period as twelve days.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Due to the nature of the complaint, the reported shortness of breath, calcification, atherosclerotic plaque, hypertension experienced by the patient could not be confirmed and the exact cause could not be determined.These clinical events do not represent evidence of a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.The anxiety experienced by the patient does not represent a device malfunction.Anxiety, part of the body¿s natural response to stress and can cause feelings of, but not limited to, nervousness, mental anguish, fear, unease and worry.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 in the legal brief, a 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, physical and emotional damages from tilting and perforation of the filter and the resultant symptoms.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.Per the medical records provided, approximately fifteen years and ten months after the filter was implanted, the patient underwent an abdominal computed tomography (ct) scan indicated for filter evaluation.The report findings noted a trapease-shaped inferior vena cava filter with the filter axis tilted to the right by eight degrees in the coronal plane.Six peripheral struts were visualized tenting the inferior vena cava wall (grade 1 perforation), and a faint small central calcification was noticed in the filter.Also noticed, a prominent surgical clip adjacent to the posterior aspect of the upper inferior vena cava.Other incidental findings included a small cyst in the right anterior liver dome; a distended gallbladder filled with gallstones and sludge material; the right kidney surgically absent; moderate calcified atherosclerotic plaques in the lower aorta and significant degenerative disk disease at t12-l1 with osteosclerosis of the margins and anterior spurs.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately fifteen years and ten months post implantation.The patient reports filter tilting and abutting against the inferior vena cava (ivc) wall.According to the information received in a redacted amended patient profile form (ppf), the patient further reports filter fracture, migration of fractured filter struts; fractured filter struts retained within the vena cava wall and an an unsuccessful percutaneous retrieval procedure; however, there have been no documented attempts to remove the filter, and no findings of free fractured fragment of the filter or migration identified by the abdominal ct scan.The patient additionally reports embedment, blood clots, clotting and or occlusion of the ivc, increased respiratory rate, heart rate and blood pressure; shortness of breath (rendering the patient unconscious) and anxiety related to the filter.

• Brand Name: 466P306X
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9529861
• MDR Text Key: 182557965
• Report Number: 1016427-2019-03706
• Device Sequence Number: 1
• Product Code: DTK
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 46 YR