Model Number N/A |
Device Problems
Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Muscle Spasm(s) (1966); Weakness (2145); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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 the "patient received a cook gunther tulip on (b)(6) 2008 at (b)(6)." it is alleged that 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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Blank fields on this form indicate the information is unknown or unavailable.(b)(4).Evaluation- the product was not returned to assist with the investigation.No information regarding the event was provided.No notes of relevance found in the device work order, nor on the filter lot number.No other complaints have been received relevant to this lot.Impossible to comment on the alleged injuries.Device manufactured/inspected according to specifications.There is no evidence to suggest the device was not manufactured to specifications.No evidence to suggest a device failure.We have notified appropriate personnel and will continue to monitor for similar events.If additional information is received, the report will be reopened for further investigation.
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Event Description
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It is alleged that the "patient received a cook gunther tulip on (b)(6) 2008 at (b)(6) in (b)(6)." it is alleged that 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).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 10/07/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2008 via the right femoral vein due to mva trauma with multiple fractures.Plaintiff alleges attempted retrieval on (b)(6) 2008.Plaintiff is alleging device is unable to be retrieved, chest pain, lightheaded, muscle spasms, weakness in arms.
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Manufacturer Narrative
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Additional information: (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 is unable to be retrieved, chest pain, lightheadedness, muscle spasms, weakness in arms.Cook will reopen its investigation if further information is received.Unknown if the reported chest pain, lightheaded, muscle spasms, weakness in arms is directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.
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Manufacturer Narrative
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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 its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.
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Event Description
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Dated 17sep2008, operative note (attempted filter retrieval) reports, "despite successful ensnarement of the retrieval hook and engagement of the sheath around the filter, the feet would not release from the walls of the ivc.Therefore the filter was left in place.".
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Search Alerts/Recalls
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