MAUDE Adverse Event Report: CORDIS CORPORATION 466F230AF; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	466F230AF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported by the legal department, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, malfunction, including perforation, fracture and perforation abutting organ that causes injury and damage to the plaintiff.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.The following additional information was received per the patient¿s implant records: the filter was implanted due to the patient has significant pulmonary embolism and deep vein thrombosis and it was felt prudent to insert an ivc filter, to protect him from another massive pulmonary embolus which could potentially be fatal.Concomitant devices: cook sheath.Relevant tests: venogram was performed (b)(6) 2016.According to the information received in the patient profile form (ppf), patient became aware of the reported events approximately 3yrs post implantation.The patient reports they live with anxiety having a filter that could fail further at anytime but cannot be retrieved with out a serious surgery.The are worried that the filter could perforate outside of the vena cava and abutting an adjacent organ.
Additional Manufacturer Narrative
After further review of additional information received.It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation, fracture and perforation abutting organ.The patient reported becoming aware of perforation of filter strut(s) outside the inferior vena cava and abutting an organ approximately three years and five months post implant.The patient indicated in the updated information that the filter was not fractured.The patient also reported anxiety related to the filter.According to the implant record the indication for the filter implant was significant pulmonary embolism and deep vein thrombosis.The filter was placed via the right femoral vein and deployed in the infrarenal portion of the ivc.Pre-deployment venogram localized the renal vein and determined that no clots or masses were seen in the ivc.Post-deployment confirmed good placement.There is currently no additional information available for review.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 optease 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Perforation of the small bowel was reported; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural and long-term complications associated with ivc filters.The ifu also 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.With the very limited information and no imaging available for review the reported events could not be confirmed or further clarified.As such, it is not possible to draw a conclusion between the reported events and the filter.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information currently available for review, 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.

• Brand Name: 466F230AF
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11099126
• Report Number: 1016427-2020-04688
• Device Sequence Number: 4037777
• 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: K034050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 07/31/2017
• Device Model Number: 466F230AF
• Device Catalogue Number: 466F230AF
• Device Lot Number: 17057056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK SHEATH.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 69 YR