Catalog Number UNKNOWN |
Device Problems
Difficult to Remove (1528); Insufficient Information (3190)
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Patient Problems
Pulmonary Embolism (1498); Myocardial Infarction (1969); Great Vessel Perforation (2152); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog is unknown but referred to as cook celect filter.Expiration date: unknown as lot # is unknown.(b)(4).Since catalog # is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Mfr date unknown as lot# is unknown.Investigation is still in progress.
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Event Description
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Description of event according to short form complaint filed: it is alleged that "[pt] received a celect filter on (b)(6) 2013." patient outcome: it is alleged that [pt] 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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Manufacturer reference # (b)(4).Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).(b)(4).Corrected data based on new information received: adverse event to product malfunction.Serious injury to malfunction.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 07/11/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the right common femoral vein due to bilateral massive pulmonary embolism and femoral dvt.Plaintiff is alleging saddle pulmonary embolism, myocardial infarction, right ventricular strain.Plaintiff is alleging vena cava perforation, device is unable to be retrieved.
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Manufacturer Narrative
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Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).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 ¿device unable to be retrieved, saddle pe, myocardial infarction, right ventricular strain, vena cava perf.".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.Unknown if the reported myocardial infarction and right ventricular strain is directly related to the filter and unable to identify a corresponding failure mode at this point in 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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