It was reported that the o-ring on the ventricular assist device (vad) was damaged.In addition to the damage, the o-ring was not in its proper position, resulting in implant difficulty.The ventricular assist device (vad) was exchanged.No patient complications have been reported as a result of this event.
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Product event summary: the o-ring from pump was returned for evaluation.Review of the manufacturing documentation confirmed that the pump and associated o -ring met all requirements for release.Failure analysis of the returned device revealed a cut in the o-ring, most likely introduced during the installation process.As a result, the reported event was confirmed.There is no evidence to suggest that a device malfu nction caused or contributed to the reported event.An internal investigation was opened to evaluate o-ring damages and implement corrective actions as required.Based on this investigation, the most likely root cause of the reported event can be attributed to multiple factors such as possible variation in the sewing ring gap that may result in variation in the effective diameter of the sewing ring as assembled and the angle of insertion by physician during implant.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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