Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Pulmonary Embolism (1498); Heart Failure (2206); No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Type
Injury
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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 "[pt] received a cook gunther tulip filter on (b)(6) 2007 at (b)(6) hospitals and clinics in (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).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.
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Event Description
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It is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2007 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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(b)(4).The event is currently under investigation.A supplemental report will be provided upon completion.
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Event Description
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Per additional information received on february 13, 2017: it is alleged the patient suffered from a massive pulmonary embolism, causing right heart failure and thromboembolic pulmonary hypertension requiring bilateral pulmonary thromboendarterectomy.The filter is retained.
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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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The lot number was not provided and is unknown.It has not been possible to investigate or evaluate this alleged 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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Search Alerts/Recalls
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