Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Myocardial Infarction (1969); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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The event is currently under investigation.A supplemental report will be submitted upon completion.
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Event Description
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It is alleged that [pt] received a cook gunther tulip on (b)(6) 2008.It is alleged that the patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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Investigation is reopened due to additional information provided.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿gunther tulip implanted".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
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Event Description
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This additional information received on 20nov2017 as follows: [pt] allegedly received an implant on (b)(6) 2006 via the right inferior jugular vein due to blood clots in the legs, stroke and heart attack.Pt is alleging stroke.
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Manufacturer Narrative
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Additional information: investigation - it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'tulip, post implant stroke'.Cook will reopen its investigation if further information is received.Unknown if the reported post implant stroke is directly related to the filter and unable to identify corresponding failure mode(s) at this time.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.
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Search Alerts/Recalls
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