MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; VENA CAVA FILTER

Model Number N/A

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Occlusion (1984); Swelling (2091)

Event Date 06/04/2013

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is a trapease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.As reported in the legal brief young vs.Cordis, an unspecified period of time after an trapease vena cava filter was implanted, the filter reportedly malfunctioned causing injury and damages including but not limited to blood clots, clotting and occlusion, of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.The trapease 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.Clots, blood clots and occlusion do not represent a device malfunction.The reported events could not be confirmed without films for review.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 event is 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 in the legal brief (b)(6) vs.Cordis, an unspecified period of time after an trapease vena cava filter was implanted, the filter reportedly malfunctioned causing injury and damages including but not limited to blood clots, clotting and occlusion, of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.The following additional information received per the patient profile form (ppf) indicates that the patient became aware of the reported events four years and four moths post implantation.The patient also reports to be suffering from stress, anxiety, swelling of the left leg and problems with urination.Additional information is pending and will be submitted within 30 days upon receipt.

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 damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc).As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which require or required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer medical expenses, pain and suffering, and other damages.Per the patient profile form (ppf), the patient became aware of the reported events four years and four moths post implantation.The patient also reports to be suffering from stress, anxiety, swelling of the left leg and problems with urination.The product was not returned for analysis.A review of the device history record (dhr) associated with lot r0708419 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Swelling of the legs and difficulty urinating do not represent device malfunctions and may be related t underlying patient issues.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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.According to the information received from the short form, the patient reports physical and emotional damages from blood clots, clotting, occlusion of the filter and resultant symptoms.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.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 damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc).Per the patient profile form (ppf), the patient reports stress, anxiety, swelling of the left leg and problems with urination.According to the information received from the short form, the patient reports physical and emotional damages from blood clots, clotting, occlusion of the filter and resultant symptoms.The filter remains implanted; thus, unavailable for analysis.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Swelling of the legs and urinary difficulty do not represent a device malfunction and may be related to underlying patient related issues.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: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6605998
• MDR Text Key: 76480554
• Report Number: 1016427-2017-00321
• 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,Followup,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0708419
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/12/2017
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR