Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: age or date of birth, outcomes attributed to adverse event, event, relevant tests/laboratory data, brand name, pma/510k, type of reportable event, device manufacture date.Investigation the following allegations have been investigated: pulmonary embolism (pe), death, sepsis, acute or chronic respiratory failure.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.Unknown if the reported death, sepsis, and acute or chronic respiratory failure are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Patient allegedly received an implant on (b)(6)2010 due to pulmonary embolism (pe) and congestive heart failure.Allegations include: death ((b)(6)2010), sepsis, acute or chronic respiratory failure, pulmonary embolism.Per certificate of death, dated (b)(6)2010, immediate cause of death is sepsis due to acute or chronic respiratory failure due to chronic obstructive pulmonary disease (copd) due to pulmonary embolism.
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