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| Catalog Number UNK LINX MAGNETIC IMPLANT |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Death (1802); Sepsis (2067); Hernia (2240); Perforation of Esophagus (2399); Foreign Body In Patient (2687); No Code Available (3191)
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| Event Date 07/01/2019 |
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Event Type
Death
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Manufacturer Narrative
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(b)(4).Date of event: unknown, assumed the 1st day of the month that complaint was reported.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.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: when available, do you have the linx product code? do you have the lot number and serial number (if applicable)? on what date was the device implanted? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? please specify the symptoms the patient was experiencing prior to implant (gerd reflux, dysphagia, pain during eating, at night, etc., )? please specify the symptoms the patient was experiencing while the device was implanted (gerd reflux, dysphagia, pain during eating, at night, etc.)? had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? if yes, what diagnostic testing was done and have they received the test results? do we have permission to contact the physician that performed the explant? if yes, what is the surgeon's name, email address, physical address and telephone number.Did they have an autoimmune disease? has the patient been prescribed medication? if yes, why was the medication prescribed? was the medication prescribed to treat the dysphagia, gerd, etc.Were they taking this medication prior to implant? are they currently taking steroids / immunization drugs? was a new linx device implanted when the explant was done? what is the current patient status? response received: explant delayed until (b)(6).Report of recurrent reflux and spasm.Linx has migrated into the chest (original surgery 1 year ago by mr (b)(6) and mr (b)(6)).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.How was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? did they place the linx between the vagus nerve and the esophagus? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? is the explant of the linx device still scheduled for (b)(6) 2019? what is product code of the linx device? what is the lot number for the linx device?.
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Event Description
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The linx device was removed on (b)(6).No more details at this time.
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Manufacturer Narrative
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(b)(4).Date sent: 10/28/2019.Additional information received: is the device available for return? no, it was disposed of.
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Manufacturer Narrative
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(b)(4).Additional information received: per the surgeon, the patient died and will be going to a coroner¿s inquest.In a conversation with (b)(6) regarding the patient who had a fatal complication.We clarified the difference between migration and erosion.I asked him what his opinion and he is responded: the patient had a big hernia and the hiatus was enforced with a mesh; the revision and removal of the slipped (migrated) linx was extremely difficult.The patient had developed an esophageal leak after and passed away due to the sepsis.We agreed that a big hernia is to handle with care and also mentioned in the ifu.We agreed that the perioperative multidisciplinary care (dietitian, nutritionist) is essential to avoid complications.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.Is a copy of the coroner¿s report available? if yes, please send to productcomplaint1@its.Jnj.Com.Did the linx device move based on the hernia or did the linx device move relative to where it was placed? can you please share a time line of events, starting with the removal that took place on tuesday, (b)(6)? is the device available for return? is the physician willing to speak with ethicon medical and engineering? what was the size of the hiatal hernia? what mesh was used (brand name)? how was the mesh fixated? how was the esophageal leak identified? how was the leak treated? what was the size of the linx device implanted? how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? did they place the linx between the vagus nerve and the esophagus? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? when did the recurrent reflux begin? what is product code of the linx device? what is the lot number for the linx device?.
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Manufacturer Narrative
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(b)(4).Additional information received: update will be provided by hospital once they have completed their investigation - no further information available at this time.
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Manufacturer Narrative
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(b)(4).Date sent: 03/06/2020.Additional information was requested, and the following was received: is a copy of the coroner¿s report available? no.Inquest not undertaken yet.Did the linx device move based on the hernia or did the linx device move relative to where it was placed? this was not a focus of the si investigation.The surgeons may be able to provide this.Can you please share a time line of events, starting with the removal that took place on tuesday, (b)(6)? it was not removed on (b)(6), but rather on (b)(6).The patient had a re-op on (b)(6) to close a oesophageal leak.A t-tube was inserted.She continued to deteriorate following that and after extensive intensive care, passed away on (b)(6).Is the physician willing to speak with ethicon medical and engineering? what was the size of the hiatal hernia? would need to check with the surgeons.What mesh was used (brand name)? this was not a focus of the si investigation.The surgeons may be able to provide this.How was the mesh fixated? this was not a focus of the si investigation.The surgeons may be able to provide this.How was the oesophageal leak identified? ct scan with contrast.How was the leak treated? thoaracotomy, washout, t-tube insertion.What was the size of the linx device implanted? this was not a focus of the si investigation.The surgeons may be able to provide this.How was the migration of the device diagnosed (chest x-ray, oesophageal line at explant)? ct scan.Are there images available that shows the migration? yes.Did they place the linx between the vagus nerve and the oesophagus? yes.Was ph testing performed prior to explant to confirm recurrent reflux? no.After implant, was the device initially effective in controlling reflux? yes.When did the recurrent reflux begin? 4 to 6 months after.What is product code of the linx device? this was not a focus of the si investigation.The surgeons may be able to provide this.What is the lot number for the linx device? this was not a focus of the si investigation.The surgeons may be able to provide this.
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Manufacturer Narrative
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(b)(4).Date sent: 05/14/2020.Additional information received: the coroner¿s inquest has not yet been undertaken.Device failure was not what was being investigated.Did the linx device move based on the hernia or did the linx device move relative to where it was placed? this was not a focus of the si investigation.In march 2019, ct scan performed showed a recurrence of the hiatus hernia (giant i.E.Very large) ¿ big portion of the stomach herniated into the mediastinum, from what the scan showed, the linx was still sitting around the distal oesophagus and obviously moved with the hiatus hernia.In june 2019, endoscopy was done which also confirmed a recurrence of the hiatus hernia (large) and no erosion of the linx at this stage.Linx was in distal oesophagus i.E.? in position, but without op notes from 2018 (where exactly it was placed i.E.Og junction or distal oesophagus), with no mention that it has moved out of place.The presence of capsule around the linx indicated that it was ¿plastered down¿, therefore, unlikely to have moved.Even if it moved, it would not be anything significant.Hence, the linx moved with the recurrence of the hiatus hernia but stayed in place in ¿distal¿ oesophagus.Majority of stomach had herniated into the mediastinum/chest with volvulus.Update from 2018 operation notes - teflon buttress (reinforcement for crura in case tissue is weak ¿ but on this occasion, no comment on quality of crura) to crura before cryopexy (stitching crura together) using ethibond 0/0 suture, 1 x anterior, and 2 x posterior.It would indicate the lynx device moved because the part of the oesophagus / stomach moved ¿ not because the device failed.
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Manufacturer Narrative
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(b)(4).Date sent: 04/22/2020.Additional information was requested, and the following was obtained: no.Inquest not undertaken yet.Did the linx device move based on the hernia or did the linx device move relative to where it was placed? this was not a focus of the si investigation.In (b)(6) 2019, ct scan performed showed a recurrence of the hiatus hernia (giant i.E.Very large) ¿ big portion of the stomach herniated into the mediastinum, from what the scan showed, the linx was still sitting around the distal oesophagus and obviously moved with the hiatus hernia.In (b)(6) 2019, endoscopy was done which also confirmed a recurrence of the hiatus hernia (large) and no erosion of the linx at this stage.Linx was in distal oesophagus i.E.? in position, but without op notes from 2018 (where exactly it was placed i.E.Og junction or distal oesophagus), with no mention that it has moved out of place.The presence of capsule around the linx indicated that it was ¿plastered down¿, therefore, unlikely to have moved.Even if it moved, it would not be anything significant.Hence, the linx moved with the recurrence of the hiatus hernia but stayed in place in ¿distal¿ oesophagus.Majority of stomach had herniated into the mediastinum/chest with volvulus.Can you please share a timeline of events, starting with the removal that took place on tuesday, (b)(6)? it was not removed on (b)(6), but rather on (b)(6).The patient had a re-op on (b)(6) to close a oesophageal leak.A t-tube was inserted.She continued to deteriorate following that and after extensive intensive care, passed away on (b)(6).Is the physician willing to speak with ethicon medical and engineering? would need to check with the surgeons what was the size of the hiatal hernia? it would appear that the hiatus hernia was 4.7cm according to the manometry study (b)(6) 2016 before the original operation.We were unable to see any further tests such as endoscopy or ba swallow or ct scan from this date to date of surgery so are cannot comment whether the hernia was the same from 2016 till 1st operation in 2018.Therefore, on the day of the original surgery in (b)(6) 2018, this hiatus hernia could be the same size or larger what mesh was used (brand name)? this was not a focus of the si investigation.No mesh was used on this occasion how was the mesh fixated? this was not a focus of the si investigation.It would appear teflon pledgets were used to reinforce the crural repair in 2018.No mesh was used on this occasion.Further crural repair was carried out in 2019 using sutures.How was the oesophageal leak identified? ct scan with contrast how was the leak treated? thoracotomy, washout, t-tube insertion what was the size of the linx device implanted? this was not a focus of the si investigation.Cannot comment further on linx size, code, number, without the original op in 2018.How was the migration of the device diagnosed (chest x-ray, oesophageal line at explant)? ct scan are there images available that shows the migration? yes.Did they place the linx between the vagus nerve and the oesophagus? yes.Was ph testing performed prior to explant to confirm recurrent reflux? no.After implant, was the device initially effective in controlling reflux? yes.When did the recurrent reflux begin? 4 to 6 months after what is product code of the linx device? this was not a focus of the si investigation.The surgeons may be able to provide this.What is the lot number for the linx device? this was not a focus of the si investigation.The surgeons may be able to provide this.
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