MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVABLE FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	466F230AF
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported by the preserve trial data, optease retrievable vena cava filter was placed as prophylaxis in the absence of deep vein thrombosis (dvt) or pulmonary embolism (pe).The patient was admitted to the hospital, consented and the device was placed without complication.The patient was discharged fourteen days post-implantation.Eighteen days post-implantation, the patient presented for ivc filter retrieval.Venogram during procedure identified that there was significant near occlusive thrombus of the entire ivc from the iliac bifurcation and radiating up to the apex of the filter.Occlusion was approximately seventy percent (70%) with partial flow beyond the filter.Manual aspiration thrombectomy of the filter was performed to remove a significant amount of thrombus and to improve the flow channel.However, filter retrieval could not be performed due to the thrombus.Therefore, forty-nine days post implantation, the patient decided to withdraw from the study since the patient was in an extended care facility and the filter retrieval was unsuccessful at which time the acute thrombus was considered ongoing.The principal investigator (pi) considered the event expected and possibly related to the device.The patient was taking rivaroxaban (xarelto) at the time of enrollment and at the time of hospital discharge.The patient¿s current status was not provided as adverse event was ongoing when the patient withdrew from the study, hence no further follow-up was possible.Additional procedural details were requested but are unknown.The product was not returned for analysis.A product history record (phr) review of lot 17693382 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter retrieval difficulty¿ and ¿thrombosis¿ could not be confirmed as the device was not returned for analysis, nor were procedural images provided for review.The exact cause could not be determined.Patient and procedural factors such as inadequate anticoagulation and antiplatelet therapy may have contributed to the reported event.According to the safety information in the instructions for use ¿warnings the optease retrievable filter can be retrieved up to and including 12 days after placement.The optease retrievable filter is considered a permanent implant if it is not retrieved within the specified time period.Possible procedure complications include, but are not limited to, the following: thrombus formation.¿ neither the phr 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.
Event or Problem Description
As reported by the preserve trial data, optease retrievable vena cava filter was placed as prophylaxis in the absence of deep vein thrombosis (dvt) or pulmonary embolism (pe).The patient was admitted to the hospital, consented and the device was placed without complication.The patient was discharged fourteen days post-implantation.Eighteen days post-implantation, the patient presented for ivc filter retrieval.Venogram during procedure identified that there was significant near occlusive thrombus of the entire ivc from the iliac bifurcation and radiating up to the apex of the filter.Occlusion was approximately seventy percent (70%) with partial flow beyond the filter.Manual aspiration thrombectomy of the filter was performed to remove a significant amount of thrombus and to improve the flow channel.However, filter retrieval could not be performed due to the thrombus.Therefore, forty-nine days post implantation, the patient decided to withdraw from the study since the patient was in an extended care facility and the filter retrieval was unsuccessful at which time the acute thrombus was considered ongoing.The principal investigator (pi) considered the event expected and possibly related to the device.

• Brand Name: OPTEASE RETRIEVABLE FILTER
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9752948
• Report Number: 1016427-2020-03865
• Device Sequence Number: 14212387
• Product Code: DTK
• UDI-Device Identifier: 20705032072899
• UDI-Public: 20705032072899
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 466F230AF
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17693382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 89 YR