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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Type
Death
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Manufacturer Narrative
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The date of the reported death is not known.The information received indicates (b)(6) 2016.Additional information was requested on this event, but was not available.Should it become available a supplemental report will be submitted.
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Event Description
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The complaint information was received after review of a private social media group, which includes 1713 vascular and interventional surgeons in (b)(6).The information reported within the group indicates that there were 2 deaths associated to the venaseal within the us in (b)(6) 2016.No other information of these reported events are available.
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Manufacturer Narrative
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Investigation results: medtronic was unable to track the social media posting to an original source or individual through its investigation.The reported deaths have not been confirmed, and it is also unknown if they were caused by or related to the venaseal closure system.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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Search Alerts/Recalls
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