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

Catalog Number 466P306AU

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, the patient underwent placement of trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter thrombosis post implant.As a direct and proximate result of these malfunctions, the patient has suffered life-threatening injuries and damages, and required extensive medical care and treatment.The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots.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

Additional information was received with updates made to the following sections: (b)(4).Additional information provided on the patient profile form (ppf)indicated that the filter is embedded in the wall of the inferior vena cava (ivc), there is blood clots, clotting and/or occlusion of the ivc and the filter can¿t be removed as it is felt it¿s too risky since it¿s been greater than ninety days since it was implanted.There have been no documented attempts to retrieve the filter.The patient is also reported to have complete occlusion of the vena cava and fear of possible device failure in the future.Information contained in the medical records indicated that the filter was placed via the right groin, using ultrasound guidance, which demonstrated a patent common femoral vein.Contrast injection of the ivc demonstrated a normal caliber patent ivc.The renal veins were identified, and the filter was deployed in the infrarenal ivc.The procedure was uneventful easily tolerated.The indication for the filter placement has not been provided.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter thrombosis post implant, that the filter is embedded in the wall of the inferior vena cava (ivc), there is blood clots, clotting and/or occlusion of the ivc and the filter can¿t be removed as it is felt it¿s too risky since it¿s been greater than ninety days since it was implanted.There have been no documented attempts to retrieve the filter.The patient is also reported to have complete occlusion of the vena cava and fear of possible device failure in the future.Information contained in the medical records indicated that the filter was placed via the right groin, using ultrasound guidance, which demonstrated a patent common femoral vein.Contrast injection of the ivc demonstrated a normal caliber patent ivc.The renal veins were identified, and the filter was deployed in the infrarenal ivc.The procedure was uneventful, easily tolerated.The indication for the filter placement has not been provided.There is currently no additional information available for review.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 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.The predominant concern for embedding with in 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.Endothelialization has been shown to occur in as short a period as 12 days.Without films of the index procedure or post implant imaging, the reported blood clots, clotting and/or occlusion of the ivc could not be confirmed or further clarified at this time.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could not be confirmed.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported events and the device.Given the limited information currently 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 trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, filter thrombosis post implant.As a direct and proximate result of these malfunctions, the patient has suffered life-threatening injuries and damages, and required extensive medical care and treatment.The patient will require continued close monitoring of the filter, medications to reduce the risks of new blood clots.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 device was not returned for analysis.A device history record (dhr) review could not be conducted as the sterile lot number was not provided.The trapease 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.Thrombosis and treatment for thrombosis does not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7145985
• MDR Text Key: 95759992
• Report Number: 1016427-2017-00910
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15105359
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 12/27/2017; 06/04/2018; 07/04/2018
• Supplement Dates FDA Received: 01/07/2018; 07/02/2018; 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 85 YR