MAUDE Adverse Event Report: CORDIS CASHEL 466P306AU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306AU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Thrombosis (2100)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.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 upon receipt.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and/or occlusion of the ivc and pain post implant.The patient suffered life-threatening injuries and damages, requiring 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

As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.Per the medical record, the patient has a history of pulmonary embolism and right leg deep vein thrombosis.During the filter implantation procedure, the filter was deployed via the left femoral vein into the level of l2-l3 without immediate complications.A left femoral venogram was performed and showed good flow of dye in the left iliac vein with no evidence of any thrombus.The patient tolerated the procedure well.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and/or occlusion of the ivc and pain post implant.Per the patient profile form (ppf), the patient became aware of the alleged events ten years and nine months post implantation.A ct scan of the trapease filter showed evidence of chronic thrombosis.The patient reports emotional distress, mental anguish, anxiety and stress.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.Anxiety and pain do 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

Complaint conclusion: as reported, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, blood clots, clotting and/or occlusion of the ivc and pain post implant.The patient suffered life-threatening injuries and damages, requiring 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.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.The inferior vena cava (ivc) 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 available for review, it is not possible to clarify the location (proximal or distal) of the clots to the placement of the ivc filter.The presence of blood clots do not represent a device malfunction.Placement of a vena cava filter is not a cure for clots nor does it prevent the formation of new clots (thrombosis).Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.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.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design, manufacturing process or implantation of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• Brand Name: 466P306AU
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary
• MDR Report Key: 7612235
• MDR Text Key: 111430147
• Report Number: 1016427-2018-01548
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306AU
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0905143
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR