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

Catalog Number 466P306AU

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

Patient Problem Pulmonary Embolism (1498)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

Exact date of implant is unknown.The filter was implanted on or about (b)(6) 2012.As reported, the patient underwent placement of defendants' trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, post-implant pulmonary 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.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.Recurrent pulmonary embolism is a known potential complication of filter implantation and is listed in the instructions for use (ifu) as such.There are possible patient and pharmacological factors that may have contributed to the reported event.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.

Event Description

As reported by the legal brief, the patient underwent placement of defendants' trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, post-implant pulmonary 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 a trapease inferior vena cava (ivc) filter.The following additional information received per the patient profile form (ppf) indicates the device was implanted due to deep vein thrombosis.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, post-implant pulmonary 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.The patient is reported to continue to experience anxiety relating to the device.The filter remains implanted; thus, unavailable for analysis.A device history record (dhr) review of lot 17629563 revealed no anomalies or non-conformances 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 pulmonary embolism 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.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6904208
• MDR Text Key: 87778103
• Report Number: 1016427-2017-00641
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15596520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR