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Catalog Number LXMC14 |
Device Problems
Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Adhesion(s) (1695); Dysphagia/ Odynophagia (1815); Nausea (1970)
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Event Date 08/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date sent: 11/9/2023.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? on what date did the explant take place? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? besides the reported dysphagia, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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A linx was explanted due to dysphagia.
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Manufacturer Narrative
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(b)(4).Date sent: 12/7/2023.Investigation summary: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device with significant tooling marks in some beads.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed for the finished device 28327 number, and no non-conformances related to the malfunction were identified.Additional information was requested, and the following was obtained: egd/bravo on (b)(6) 2022; small hiatal hernia, demeester 37.6.On what date did the implant take place? (b)(6) 2022.On what date did the explant take place? (b)(6) 2023.What is the lot number of the linx device? 28327.When using the linx sizing device what technique was used to determine the size? the circumference of the esophagus was measured just proximal to the esophagogastric junction using the sizing device.Generally, the linx selected is 3 beads larger than the actual size.Did the patient have an autoimmune disease? no known autoimmune disease.Is the patient currently taking steroids / immunosuppressive drugs? none known.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? she had a normal marshmallow bagel barium swallow with 2 stripping waves for both.How severe was the dysphagia/odynophagia before intervention? patient states she required iv therapy to stay hydrated and had concern of her kidney function.All labs were normal.Egd dilation was done on (b)(6) 2023, with relief for about 1 month patient was able to eat food but was challenged with drinking thin liquids.She states she was eating minimally and gained 40lbs while eating 800 calories per day.She was referred to a nutritionist and was having an evaluation of her thyroid with an endocrinologist.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? no.Besides the reported dysphagia, what was the reason for removal of the linx device? patient also had nausea.Was the device found in the correct position/geometry at the time of removal? per op note: immediately identified were inflammatory adhesions to the superior undersurface of the left lateral lobe of the liver-these adhesions were gently divided which allowed for identification of the linx device.Per upper gi series on (b)(6) 2023- a linx device is noted at the ge junction.1.Intermittent persistence of liquid within the esophagus.2.Nonmotile and dysmotile esophageal contractions with esophageal reflux.
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Search Alerts/Recalls
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