Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.
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Event Description
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It is alleged that the patient received a gunther tulip filter on (b)(6) 2006 at (b)(6)."
it is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.Supplemental report will be submitted upon completion.
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Event Description
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It is alleged the patient received a gunther tulip filter on (b)(6) 2006 at (b)(6).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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According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
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Event Description
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This additional information received on 01/22/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right femoral vein due to pe with contraindications to anticoagulation.Plaintiff is alleging other: mental anguish/anxiety.Other: suffered from a stroke in 2009 or 2011 affecting memory, peripheral vision and causing leg weakness, other: pain in groin and leg.
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Manufacturer Narrative
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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 ¿pain in groin and leg, mental anguish/anxiety, stroke in 2009 or 2001".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Unknown if the reported stroke is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the pain in the groin and leg is directly related to the deployment procedure.Will be reinvestigated when more information becomes available.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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