Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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An endurant limb (etlw1620c82ej) was intended to be implanted during the treatment of an internal iliac abdominal aneurysm.It was reported during the index procedure, intraoperative measurement for the endurant limb was conducted using a pigtail catheter and based on the measurement an 82 mm length limb was selected.Upon placement, it was discovered that the stent was too short, and length was insufficient distance from the bifurcation.When the limb was delivered it was thought to be 10mm too short.The device was withdrawn from the patient and was replaced with 93 mm limb instead.The etlw1620c82ej was discarded without being deployed.Per the physician the cause of the incorrect size selected for patient is undetermined. no additional clinical sequalae were provided and the patient is fine.
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