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Description of event according to the initial reporter: this patient had undergone placement of a cook celect filter 24 weeks prior to presentation for filter retrieval.Preprocedure ct showed the right hook of the ivc filter to be protruding into the right renal artery.Cavagram showed an angulated filter with an embedded hook and therefore bronchial forceps were used.After technically successful filter retrieval, the patient developed hypotension and right sided flank pain.Ct showed a right sided retroperitoneal hemorrhage and an infarcted right kidney.Angiogram was done demonstrating a fistula between the right renal artery and ivc and the renal artery was embolized with a 12mm amplatzer vascular plug.In this case, with pre-procedure ct evidence of the hook penetrating into the renal artery, obtaining arterial access could have been done to allow imaging and potential treatment of any renal arterial disruption during retrieval." patient outcome: according to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient did require additional procedures due to this occurrence.
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Manufacturer ref# (b)(4).Summary of investigational findings: this complaint is based on the information provided from the journal article: procedural complications of inferior vena cava filter retrieval, an illustrated review" by keith b.Quencer et al, published 27apr2020, figure 2.It concerns a celect-pt filter which after 24 weeks dwell time is observed to have perforated the renal artery.The filter was removed with forceps but after retrieval the patient developed hypotension and right sided flank pain.Ct showed a right sided retroperitoneal hemorrhage and an infarcted right kidney.Angiogram was done demonstrating a fistula between the right renal artery and ivc and the renal artery was embolized with a 12mm amplatzer vascular plug.Based on the imaging in the article an imaging review was provided.Per imaging reviewer´s findings: ¿figure 2 contains 2 coronal images from a ct scan, 2 fluoroscopic images from a venogram at time of filter retrieval and 2 fluoroscopic images from an arteriogram at time of complication.Per the article, a celect ivc filter was placed 24 weeks prior to the submitted preretrieval ct scan.This demonstrates the hook of the ivc filter projecting into the lower aspect of the right renal artery on the coronal reformatted ct image.The axial images were not submitted for review to confirm hook location.However, the venogram at time of ivc filter retrieval demonstrates approximately 12° of leftward tilt.In addition, the hook of the ivc filter appears to project outside of the column of contrast suggesting penetration/embedment and corresponding with the previous ct scan.Next image demonstrates capture of the hook of the ivc filter using an endobronchial forceps device.Per the description, the retrieval was successful, however patient developed hypotension and right flank pain following retrieval.A subsequent ct scan shows large right retroperitoneal hematoma and an infarcted right kidney.Patient underwent an emergent right renal angiogram, 2 images were submitted for review which demonstrates selective angiography of the right renal artery demonstrating extravasation and what appears to be fistulous communication to the ivc which was treated with embolization using a 12 mm amplatzer plug.¿ per imaging reviewer´s impressions: ¿the article includes a number of filter brands, but this review is concentrated on the four examples of cook ivc filter related issues.Specifically figure 2, figure 6, and failure 8 are related to filter tilt and either perforation of the filter hook and/or embedment of the filter hook leading to utilization of advanced techniques to retrieve the filter and associated complication of vascular wall injury involving either the ivc wall and/or the adjacent artery as detailed above.The cause of the filter tilt was not addressed nor evaluated in this article.The original placement images were not included to determine if this tilt developed over time or if the filter was deployed with this tilt leading to the final configuration at time of retrieval.It is therefore not possible to determine if the tilt and subsequent perforation was a byproduct of the placement procedure, filter design, patient anatomy/biology or dwell time, all of which can contribute.Cases described in fig 6 and 2 were retrieved but demonstrated subsequent injury of the caval wall requiring stenting and injury to the right renal artery requiring embolization, respectively.Each of the submitted cook cases in this review article demonstrate situations where advanced techniques would or have been required to successfully retrieve the ivc filter and the associated complications from these retrievals.The cause of the filter¿s configuration requiring advanced techniques was not the concentration of this article, nor discussed in this article.This latter information is important in determining if the filter performed appropriately, or if this configuration was a result of human or device error, and unfortunately cannot retrospectively be addressed from the date included in this review.¿ cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.There are adequate controls in place to ensure that this type of filter is manufactured to specifications.Based on the provided information it is unknown what caused the filter to perforate into the renal artery.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This 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.Cook medical will continue to monitor for similar events.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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