H10: additional manufacturer narrative:the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
|
The complaint investigation was conducted, using evaluation summary (b)(4) and triage level 1, in accordance with (b)(4) rev d due diligence attempts were made to gather additional information regarding a device failure mode, however additional information is not available at this time.Patient medical records were not provided by the hospital for review, or the medical records provided do not clarify the device failure mode.Per the instructions for use (ifu), reoperation/explant are known potential adverse events associated with bioprosthetic cardiac valves and annuloplasty rings.In this case, there is no evidence of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation, no labeling non-conformance/deficiency, no use-related issue with a hazardous situation, no device-related infection, and no evidence of a product failure with regard to design, reliability, or use error.As such, neither a product risk assessment (pra) nor corrective or preventive actions (capa/scar) are required at this time, per (b)(4) and (b)(4).Based on the information available, a definitive root cause cannot be conclusively determined.
|