MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO OPTEASE RETR FILTER 55 FEMORAL; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number is: (b)(6).This device was returned for analysis and the engineering report is pending.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
Prior to a planned retrieval of a 55 femoral optease retrievable vena cava filter after 14 days, one of the struts was broken but remained attached to the filter.There was no reported patient injury.The filter was placed in inferior vena cava (ivc) properly.The indication for filter placement was deep vein thrombosis (dvt).Thrombus was present at the delivery site.Pre and post imaging were completed but the results were not provided.There was no difficulty removing the filter and no excessive force was used.The struts were not stuck to the vessel and no excessive force used to retrieve the filter.Additional patient and procedural details were requested but were not provided by the physician.The device will be returned for analysis.
Additional Manufacturer Narrative
Prior to a planned retrieval of a 55 femoral optease retrievable vena cava filter after 14 days, one of the struts was broken but remained attached to the filter.The filter was placed in inferior vena cava (ivc) properly.The indication for filter placement was deep vein thrombosis (dvt).Thrombus was present at the delivery site.Pre and post imaging were completed but the results were not provided.There was no difficulty removing the filter and no excessive force was used.The struts were not stuck to the vessel and no excessive force used to retrieve the filter.Additional patient and procedural details were requested but were not provided by the physician.There was no reported patient injury.The product was returned for analysis.Per visual analysis, a fractured separated strut condition was observed.A single photograph was provided.Per microscopic analysis, the unit was sent to identify the possible root-cause of the filter fractured separated strut condition observed.Results showed the separated strut area of the optease retrievable filter 55 femoral unit presented consistent evidence of fatigue fracture on the struts¿ separated surface areas.In addition, non metallic inclusions were observed near to the fracture origins.Ductile dimples were also observed on the struts¿ surfaces.Inclusions are non-metallic phases embedded in a metallic matrix.They are usually simple oxides, sulfides or nitrides derived from the chemical reaction of the molten metal with the local environment.Inclusions of the observed size are expected to be found in the material and are not uncommon.Fatigue fractures in this material are commonly observed to originate at inclusions such as these (becker et al., 2002).It is assumed that the observed non-metallic inclusions led to fatigue crack initiation.Ductile dimples observed on the struts¿ surfaces suggest that, although the material fatigue crack was originated due to the inclusions observed, the filter was also induced to a tensile force that resulted ultimately in the struts material separation.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17975556 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter-fractured - in patient¿ was confirmed by analysis.The exact cause of the reported event could not be conclusively determined.Procedural/handling factors, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿warning: 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, reports of adverse clinical sequelae from filter fractures are rare.Possible long-term complications associated with filter implantation include, but are not limited to, the following: filter obstruction, filter perforation of the vena cava wall, filter migration, filter fracture, recurrent pulmonary embolism.Retrieval of the cordis optease® retrievable filter with a filter fracture present may result in complications.¿ neither the phr nor the product analysis 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
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11596103
• Report Number: 9616099-2021-04376
• Device Sequence Number: 11640477
• Product Code: DTK
• UDI-Device Identifier: 20705032072899
• UDI-Public: 20705032072899
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K140286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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 Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 466F210AF
• Device Lot Number: 17975556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1