MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

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

Patient Problems Embolism (1829); Occlusion (1984); Thrombosis (2100)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of the 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, thrombosis/embolism.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.Blood clots and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.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 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, thrombosis/embolism.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.

Manufacturer Narrative

As reported, the patient underwent placement of the 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, thrombosis/embolism.Per the patient profile from (ppf), the patient reports blood clots, clotting, and/or occlusion of the ivc.The patient states that during examination of their trapease ivc filter, there is evidence of thrombosis present.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 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.Blood clots, thrombosis, embolism 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.

Manufacturer Narrative

According to the information received in the patient profile from (ppf), approximately on or about seven years and ten months post implantation of the ivc filter the patient became aware of the alleged events and reports to have blood clots, clotting, and/or occlusion of the ivc.The patient states that during examination of their trapease ivc filter, the patient was reported to have evidence of thrombosis present.These injuries have caused emotional distress, mental anguish, anxiety, and stress.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7933966
• MDR Text Key: 122658026
• Report Number: 1016427-2018-01902
• 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: 05/02/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 03/28/2019; 04/25/2019
• Supplement Dates FDA Received: 04/24/2019; 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 48 YR