MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Fracture (1260)

Patient Problems Aneurysm (1708); Thrombosis (2100)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

This is a voluntary medwatch that was received from the fda under mw5078679.It was reported that multiple fractures (at least 5 separate fractures) were observed six years after an optease inferior vena cava filter was implanted.There is no patient injury noted.The filter was removed with forceps, complicated by further filter fracture (removed) and caval pseudoaneurysm warranting hospitalization note.The filter had caused two separate episodes of caval thrombosis, one seven years ago and another four years ago which is a known issue with this filter design.The optease ivc filter was placed ten years ago and there were no prior attempt made for removal.The fractures were spontaneous.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.The formation of a pseudoaneurysm does not represent a device malfunction and may be related to underlying patient related issues.Without procedural films available for review, it is not possible to clarify the location (proximal or distal) of the caval thrombosis (blood clot) to the placement of the ivc filter.Placement of a vena cava filter is not a cure for nor does it prevent the formation clots (thrombosis).Factors that may have influenced the event include patient, pharmacological and lesion.There is no medical evidence of a causal relationship between the vena cava filter and the formation of a new thrombus.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.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.

Event Description

It was reported that there were multiply fractured (at least 5 separate fractures) was noted six years after the device was implanted.There is no patient injury.The filter was removed with forceps, complicated by further filter fracture (removed) and caval pseudoaneurysm warranting hospitalization note.The filter had caused two separate episodes of caval thrombosis, one seven years ago and another four years ago which is a known issue with this filter design.The optease ivc filter was placed ten years ago and there were no prior attempt made for removal.The fractures were spontaneous.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 00000 ; EI 00000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 00000 ; EI 00000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 7859690
• MDR Text Key: 119660803
• Report Number: 1016427-2018-01787
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention