Model Number N/A |
Device Problems
Difficult to Remove (1528); Insufficient Information (3190)
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Patient Problems
Pain (1994); Numbness (2415); Blood Loss (2597); No Information (3190)
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Event Type
malfunction
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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) 2002.¿ 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 conclusion.
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Event Description
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Additional information received 3/16/17 - patient alleges the following: an ivc filter was implanted on (b)(6) 2002 to prevent dvt in the left lower extremity with progression to common iliac vein.No attempts have been made to remove.Patient claims that device cannot be removed and bleeding.Patient also claims further dvt, pain in legs and numbness in extremities.
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Manufacturer Narrative
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Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.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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Search Alerts/Recalls
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