COOK INC GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number G21360 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Cramp(s) (2193); Numbness (2415)
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Event Type
malfunction
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Manufacturer Narrative
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The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2019-00873.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial report, cook inc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in this initial medwatch report.Occupation: non-healthcare professional.A follow-up medwatch report will be submitted if additional relevant information becomes available.
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Event Description
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Update 30 aug 2019: patient allegedly received an implant on (b)(6) 2014.Patient is alleging "i have pain in both legs, cramps, numbness.I have to elevate my legs all the time to feel better".This report is for the (b)(6) 2014 implant.A separate report will be submitted for the (b)(6) 2014 filter.
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Manufacturer Narrative
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Additional information: the following field was updated per additional information received: h6.Investigation ¿ investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: deep vein thrombosis, pain, cramps and numbness in legs.Ivc occlusion/ thrombosis, new dvt, ivc stenosis 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: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Unknown if the reported pain, cramps and numbness in legs is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of ten (10) devices were manufactured in the reported lot.To date, no other complaints have been reported against this lot.The associated work order was reviewed.No related/relevant notes were documented.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 report will be submitted should additional relevant information become 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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Event Description
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No additional information provided at this time.
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Event Description
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No new additional information received at this time.
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Manufacturer Narrative
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H6 conclusion code(s): appropriate term/code not available (4316) was selected because the previous investigation remains unchanged by the additional information.Investigation: investigation is reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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