MAUDE Adverse Event Report: CORDIS US CORP OPTEASE; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number	466F210AF
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 55 cm optease vena cava filter was pulled down to the iliac vein, and it was found that the filter had broken off in the patient's body, and it was recovered and re-released.After filter release was completed, an unknown pig contrast catheter was used to visualize the pulmonary artery, and when the catheter was withdrawn it passed through the inferior vena cava, the filter was pulled down to the iliac vein, and it was found that the filter had broken off in the patient's body, and it was recovered and re-released.There was no reported patient injury.The indication for filter insertion was deep vein thrombosis (dvt).The device was in situ for ten (10) minutes before retrieval was attempted.The access site was normal, and the retrieval access site was the femoral vein.Concomitant devices used during the retrieval attempt included an unknown guidewire and a snare.The vena cava was less than 30 mm in size and was not measured or estimated.The vessel was not calcified and had no acute bends or tortuosity.The product was stored and handled according to the instructions for use (ifu), and the device was prepped according to the ifu.There were no visible signs of device or package damage prior to use.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, the 55 cm optease vena cava filter was pulled down to the iliac vein, and it was found that the filter had broken off in the patient's body, and it was recovered and re-released.After filter release was completed, an unknown pigtail contrast catheter was used to visualize the pulmonary artery, and when the catheter was withdrawn it passed through the inferior vena cava, the filter was pulled down to the iliac vein, and it was found that the filter had broken off in the patient's body, and it was recovered and re-released.There was no reported patient injury.The indication for filter insertion was deep vein thrombosis (dvt).The device was in situ for ten (10) minutes before retrieval was attempted.The access site was normal, and the retrieval access site was the femoral vein.Concomitant devices used during the retrieval attempt included an unknown guidewire and a snare.The vena cava was less than 30 mm in size and was not measured or estimated.The vessel was not calcified and had no acute bends or tortuosity.The product was stored and handled according to the instructions for use (ifu), and the device was prepped according to the ifu.There were no visible signs of device or package damage prior to use.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18356215 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint "filter migration embolization embolization-caudal" could not be confirmed.Without films of the reported event there is not enough information to draw a definitive clinical conclusion between the device and the reported event.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration includes mega cava (ivc diameter >28 mm), wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to the fracture and migration of ivc filters.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Migration of ivc filters has been demonstrated when the presence of an overburden of thrombus in the vasculature occurs that exceeds the devices¿ ability to exert radial force toward the vessel walls and maintain optimal positioning and in patients who were in a dehydrated state when the filter was placed and have since re-hydrated thereby expanding the diameter of the vena cava.Based on the device history record review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
The device was not returned for evaluation.

• Brand Name: OPTEASE
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 20956759
• Report Number: 9616099-2024-00553
• Device Sequence Number: 12025158
• Product Code: DTK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K034050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 466F210AF
• Device Lot Number: 18356215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK GUIDEWIRE, SNARE.
• Patient Sex: Unknown