| Model Number N/A |
| Device Problems
Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Internal Organ Perforation (1987); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692); No Information (3190)
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| Event Date 03/05/2013 |
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Event Type
Injury
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Manufacturer Narrative
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Information previously submitted by (b)(4) under reference # 3002808486-2016-01234.Additional information provided on (date) determined this device was manufactured by (b)(4).The event is currently under investigation.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012".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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Evaluation- no information regarding the event.The product was not returned to assist with the investigation.We have investigated based on the information received to date, and are closing the report until further information is received for investigation.Unable to comment on the alleged injury.There is no evidence to suggest the device was not manufactured to specifications.If additional information is received, the report will be re-opened for further investigation.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012".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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According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this 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 according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2012".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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Correction: report is being submitted as a follow up # 3 as this was not previously submitted.Evaluation: investigation is reopened due to additional information provided.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¿.Cook will reopen its investigation if further information is received.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.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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Manufacturer Narrative
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Additional information: b5, b6 blank fields on this form indicate the information is unknown or unavailable.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 ¿ vena cava penetration 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 (b)(6).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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Patient alleges perforation.Attempted filter retrieval performed on 06mar2018.
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Event Description
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Patient allegedly received an implant on (b)(6) 2012 due to blood clots.The patient alleges tilt, organ perforation, and ivc stenosis.The patient further alleges stress, limited mobility, occlusive thrombus, and embedment.Attempted device retrieval on (b)(6) 2018 due to ivc filter causing 50-60% stenosis of the ivc.Successful device retrieval on (b)(6) 2018 due to multiple failed attempts, ivc stenosis.(b)(6) 2018, per a report from retrieval report (successful); ¿findings: venacavogram was performed, which demonstrates a patent ivc although it is somewhat narrowed at the site of filter implantation.The hook of the existing filter appears intraluminal, but has been straightened from prior retrieval attempt.Several of the legs of the filter project outside the lumen of the ivc.Impression: 1.Successful excimer laser sheath-assisted retrieval of an imbedded tulip ivc filter with a straightened retrieval hook from prior failed attempts.2.Pharmacomechanical: thrombectomy and venoplasty of near occlusive thrombus within the left iliofemoral stents with restoration of in line flow from the left lower extremity.3.Successful 14 mm balloon venoplasty of the infrarenal ivc at the site of ivc filter implantation with excellent venographic result.¿.
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Manufacturer Narrative
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Investigation: the following allegations have been investigated: organ perforation, embedment, stenosis/occlusive thrombus, tilt, limited mobility, stress.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation and embedment does not change the previous investigation results for vena cava perforation.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.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported limited mobility and stress is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on work order.The product 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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Search Alerts/Recalls
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