MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETR FILTER 55 FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F210AF

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

As reported, the upper basket of a 55 femoral optease retrievable vena cava filter was found fractured after the retrievable filter was implanted.The fracture was noted upon imaging confirmation, immediately after implantation, the filter was removed.The procedure was completed via normal implantation of another unknown device under digital subtraction angiography (dsa).There were no reports of patient injury.The filter was indicated for the treatment of a deep vein thrombosis (dvt).The diameter of the vena cava was less than 30mm; the vena cava was without deformities and of normal shape.There was no tortuosity of the vessel.The filter was placed ¿post cava¿.The filter was never in an acute or sharp bend in the delivery tube while it was out of the storage tube.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18106461 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the upper basket of a 55 femoral optease retrievable vena cava filter was found fractured after the retrievable filter was implanted.The fracture was noted upon imaging confirmation, immediately after implant, the filter was removed.The procedure was completed via normal implant of another unknown device under digital subtraction angiography (dsa).There were no reports of patient injury.The filter was indicated for the treatment of a deep vein thrombosis (dvt).The diameter of the vena cava was less than 30mm; the vena cava was without deformities and of normal shape.There was no tortuosity of the vessel.The filter was placed ¿post cava¿.The filter was never in an acute or sharp bend in the delivery tube while it was out of the storage tube.The device was returned for analysis.A non-sterile filter belonging a optease retr filter 55 femoral was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The filter was inspected observing that it presented a separated/fractured condition.The filter was inspected using a vision system to obtain a magnified image.The separated/fractured condition was confirmed at two strut joints.Sem results showed that both fractured sections of the unit presented evidence of plastic deformation and apparently ductile dimples.The plastic deformation along with the ductile dimples on the fractured sections are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.No other anomalies were observed during the sem analysis.A product history review of lot 18106461 revealed no anomalies during the manufacturing and inspection processes that can be considered potentially related to the reported complaint.The reported ¿filter / fractured - in patient¿ was confirmed through analysis of the returned device.The returned filter presented two struts with a separated/fractured condition.With the limited information provided and no imaging available for review an exact cause of the damage could not be conclusively determined.According to the instructions for use, which is not intended as a mitigation of risk filter fracture is a known complication associated with the implant procedure.Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.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.Neither the phr, the product analysis, nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: OPTEASE RETR FILTER 55 FEMORAL
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15578490
• MDR Text Key: 301654646
• Report Number: 9616099-2022-06051
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032073599
• UDI-Public: (01)20705032073599(17)250430(10)18106461
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F210AF
• Device Catalogue Number: 466F210AF
• Device Lot Number: 18106461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: UNKNOWN.