Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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An attempt was made to use one resolute onyx rx coronary drug eluting stent (des) to treat a lesion.The device was inspected with no issues.Negative prep was not performed.The device was not kinked and restraightened during use.Excessive force was not used during delivery.It was reported that device or component detached, cracked, or fractured.The patient is alive with no injury.
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