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| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Pain (1994); Perforation of Vessels (2135); Disability (2371); 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.Occupation: non-healthcare professional.(b)(4).It has not been possible to investigate or evaluate this alleged 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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Event Description
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Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2016".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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Event Description
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No additional information provided at this time.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(4).Additional information: evaluation codes.Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Vena cava wall penetration/perforation has been reported and may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Unknown if the reported pain, heart palpitations, sob, anxiety, disability, weakness are directly related to the filter and unable to identify a corresponding failure mode at this point in time.No relevant notes on wo (work order) for neither device or lot number.No other complaints on lot.Product is manufactured and inspected according to specifications.This report includes information known at this time.A follow-up medwatch report will be submitted if 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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Manufacturer Narrative
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Blank fields on this form indicate the information is unchanged, unknown or unavailable.Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(4).Device codes: appropriate term/code not available (3191): device perforation.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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Additional information received identified the patient allegedly received a cook celect® platinum navalign femoral vena cava filter implant on (b)(6) 2016 via the right common femoral vein due to upcoming surgery.The patient is alleging vena cava perforation and "2 required attempts to successfully remove the filter due to perforation".The patient further alleges, "persistent shortness of breath since placement of the filter (even after removal of the device), heart palpitations, severe and persistent chest pain.Significant anxiety over presence of inferior vena cava filter.Not the same after inferior vena cava filter and adrenal gland removal (hard to say if it was inferior vena cava filter or adrenalectomy or both) - fatigued, can't walk long distances, needed help with household chores.Ongoing chest pain, anxiety, shortness of breath, weak and tired all the time.Life changed completely and haven't been the same.Easily exhausted, has to do daily living activities much more slowly now".It was also reported that per the (b)(6) 2016, retrieval report (attempted): "procedure narrative: right internal jugular access with ultrasound guidance after infiltrating local anesthesia.Wire advanced below inferior vena cava filter followed by flush catheter.Several diagnostic views showed potential sidewall luminal filling defect or tynes external to the inferior vena cava wall.It was decided to not attempt removal at this time and obtain computed tomography scan to best characterize the current state of the filter".Additionally, per the (b)(6) 2016, computed tomography-abdomen and pelvis with contrast: "findings: vascular structures: there is an inferior vena cava filter seen in the lnfrarenal portion of the inferior vena cava with at least one right lateral strut seen outside of the vena cava by approximately 4 mm (coronal image 14 and axial image 40).The posterior strut on the right also appears to be outside of the vena cava, just anterior to the right psoas muscle (axial image 39), the tilter continues to be oriented cephalad as expected.No evidence of thrombus formation seen in the inferior vena cava adjacent to the filter.Impression: 2.Inferior vena cava filter with at least 2 right-sided anterior and posterior struts outside of the inferior vena cava.However, the filter is still oriented cephalad in the expected position and there is no intraluminal thrombus seen in the inferior vena cava around the filter".Per the (b)(6) 2016, retrieval report (successful): "conclusions: successful removal of an inferior vena cava filter".
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Search Alerts/Recalls
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