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

Catalog Number 466P306AU

Device Problem Fracture (1260)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Coagulation Disorder (1779); Dyspnea (1816); Thrombosis (2100)

Event Date 05/01/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: pulmonary embolism and filter fracture.As a direct and proximate result, 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, pain and suffering, and other damages.No additional information is available.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 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 for review, the reported filter fracture could not be confirmed and the exact cause could not be determined.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.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.However, 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.Please note that this is the initial/final report for this product.

Event Description

As reported through the legal department via a legal brief, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: pulmonary embolism and filter fracture.As a direct and proximate result, 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, pain and suffering, and other damages.No additional information is available.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.Per the medical record provided, the patient has a history of pulmonary embolisms and dvt.The patient was implanted with the trapease ivc filter through the right femoral vein distal to the renal vein origins.An inferior venocavagram showed satisfactory position and orientation of the filter.The patient handled the procedure well without immediate complication.The filter subsequently malfunctioned and caused injury, damage, to the patient, including, but not limited to: pulmonary embolism and filter fracture.Per the patient profile from (ppf), the patient reported chest pain, breathing difficulty, and additional blood clots in the lung.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.The instructions for use (ifu) states filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Blood clots and pulmonary embolism do not represent a device malfunction.Difficulty breathing and chest 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

According to the information received in the patient profile from (ppf), the patient reported chest pain, breathing difficulty, and additional blood clots in the lung, and dvt since the filter was implanted.According to the medical record provided, the patient has a history of pulmonary embolisms.During the implant procedure, the patient was implanted with the trapease vena cava filter through the right femoral vein caudal to the renal vein origins.An inferior vena cavogram showed satisfactory position and orientation of the filter.The patient handled the procedure well without immediate complication.After further review of additional information received the following sections have been updated accordingly.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 466P306AU
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tipperary 33152 ; EI 33152
• MDR Report Key: 7557717
• MDR Text Key: 109693450
• Report Number: 1016427-2018-01508
• 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
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R1005509
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/12/2018
• Date Manufacturer Received: 07/10/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR