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COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL
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| Catalog Number EVO-FC-R-18-23-8-E |
| Device Problems
Material Erosion (1214); Off-Label Use (1494)
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| Patient Problems
Erosion (1750); Hemorrhage/Bleeding (1888); Perforation (2001); Gastrointestinal Hemorrhage (4476)
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| Event Date 12/19/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k)#: k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Implant has eroded through esophagus into subclavian artery causing hemorrhage and need for emergency explant."as per cc form": patient admitted to (b)(4) royal at 6 weeks following successful placement of evo-e stent showing blood in vomit.Upon initial endoscopy it was noted several clots were present within the stent body and with signs of erosion/granulation at both the distal and proximal ends of the device.Patient was subsequently transferred to royal hospital for children glasgow for stent removal and further treatment.On endoscopic inspection, clot was removed to prove erosion into subclavian artery at proximal position of stent (15cm).Haemostasis achieved with senstaken tube and cardiac bypass performed to regain haemostatic control.Once isolation of the damaged artery was achieved, senstaken tube was removed along with the oesophageal stent with grasping forceps.Consultant noted no friction when removing the implant suggesting no ingrowth of tissue in to the device.Device was inspected by myself and mr paul glen to ensure no remnents were left inside patient.Mr glen did note at one stage he did grasp the implant by the mesh rather than pull tab, so may show a signs of damage to the silicone coating upon microscopic investigation.Further repair to the damaged artery was conducted and case concluded.A section of the device did not remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.Emergency retrieval of esophageal sems + cardiac bypass.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Stent erosion into subclavian artery.Please confirm if the complaint device has been used on a covid-19 patient and if the device was used on a covid-19 patient then the customer should provide photographs of the device if possible and not return the device.No.1.At what stage of the procedure did the complaint occur? when unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, or during stent repositioning/removal.N/a.Stent caused erosion during in-dwell.2.What endoscope type and channel size was used? n/a.3.What was the position of the elevator? n/a.4.Details of the wire guide used (diameter, type, make)? n/a.5.Was the zip port facing upwards and slightly curved when backloading the wire guide? n/a.6.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes.7.Please advise the anatomical location of the intended target site.Oesophagus.8.How long was the stent in the patient by the time this complaint occurred? 41 days.9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? not sure.10.If yes, how often was this completed? 11.Did the patient require any additional procedures as a result of this event? yes.12.What intervention (if any) was required? cardiac bypass + sengstaken-blakemore tube.13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same procedure.14.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no.15.If yes, please specify what was observed and where on the device it was observed.N/a.Stricture information: 1.What was the length and diameter of the stricture? not sure.2.Where was the stricture located in the body? upper esophagus.3.Was there resistance felt passing wire guide through stricture? n/a.4.Was there resistance felt passing the evolution through stricture? n/a.5.Was the stricture dilated before stent placement? n/a.Questions related to during insertion into patient.1.Was the product inspected for kinks or damage before use? n/a.2.Was resistance felt during insertion into patient? n/a.3.If yes, at what point? questions related to during stent placement.1.Did the product fail during stent deployment or recapture? n/a.2.If other, please specify.3.Was the directional button pressed during use? n/a.4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? n/a.5.Was the yellow marker kept in view during deployment? n/a.6.Are images of the device or procedure available? n/a.Questions related to during introducer withdrawal.1.Are images of the device or procedure available? n/a.2.Was final stent placement confirmed using endoscopy / fluoroscopy? n/a.3.If yes, what was used? 4.Did the stent open sufficiently to allow withdrawal of introducer safely? n/a.5.Was the safety wire fully removed before removing the delivery system? n/a.6.Did any part of the product snag/get caught with the stent when removing the delivery system? n/a.Questions related to during stent repositioning/removal (for evo-fc & evo-pc devices).1.What instrument was used for stent repositioning / removal? forceps.2.If other, please specify.3.Was resistance encountered during advancement and/or deployment? no.4.If yes, please when this was felt? advancement or deployment.5.How did the physician deal with this resistance? 6.Was the lasso (suture) loop used during repositioning yes, during removal.
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Event Description
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Correction mdr being submitted as update to section b.1 to adverse event and product problem.Also update to e, f codes.
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Manufacturer Narrative
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Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Manufacturer Narrative
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Pma/510(k) # k162717.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Supplemental report is being submitted due to completion of the lab evaluation on 16feb2023 and description of events updated based on confirmation of off label use on 23-feb-2023.Implant has eroded through esophagus into subclavian artery causing hemorrhage and need for emergency explant."as per cc form": patient admitted to aberdeen royal at 6 weeks following successful placement of evo-e stent showing blood in vomit.Upon initial endoscopy it was noted several clots were present within the stent body and with signs of erosion/granulation at both the distal and proximal ends of the device.Patient was subsequently transferred to royal hospital for children glasgow for stent removal and further treatment.On endoscopic inspection, clot was removed to prove erosion into subclavian artery at proximal position of stent (15cm).Haemostasis achieved with senstaken tube and cardiac bypass performed to regain haemostatic control.Once isolation of the damaged artery was achieved, senstaken tube was removed along with the oesophageal stent with grasping forceps.Consultant noted no friction when removing the implant suggesting no ingrowth of tissue in to the device.Device was inspected by myself and mr paul glen to ensure no remnents were left inside patient.Mr glen did note at one stage he did grasp the implant by the mesh rather than pull tab, so may show a signs of damage to the silicone coating upon microscopic investigation.Further repair to the damaged artery was conducted and case concluded.As per input from medical advisor, the use of evo-fc-r-18-23-8-e on a paediatric patients is considered off-label use.
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Event Description
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Supplemental follow-up mdr report is being submitted due to the completion of the investigation and an update to the investigation conclusions.
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Manufacturer Narrative
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Pma/510(k) # k093619.Device evaluation the 1x evo-fc-r-18-23-8-e device of unknown lot number involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 16th feb 2023.On evaluation of the device the following was observed: visual inspection: stent returned intact.Functional inspection: n/a document review prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data review historical data was not reviewed as the lot number is unknown.Ifu & label review as per the instructions for use esophageal ulceration and erosion is a known potential adverse event associated with gi endoscopy and esophageal stent placement: ¿additional complications include, but are not limited to: stent misplacement and/or migration; tumor overgrowth; dysphagia, esophageal ulceration and erosion¿.The intended use outlined in the ifu is as follows: "this device is used to maintain liminal patency of the esophagus in cases of: obstruction caused by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas." as per the 'intended use/intended purpose' section of the technical content form ( (b)(4) ) associated with this device, this stent is for use on 'adult patients requiring esophageal stenting'.The erosion of the stent through the oesophagus could be attributed to this placement, which is covered in pae in ifu as ¿esophageal ulceration and erosion¿.Image review an image was not returned for evaluation.Root cause review: a definitive root cause of off-label use was identified from the available information.It was noted from the patient information received that the patient was 5 years of age at the time of the event.As the evolution® esophageal stent system ¿ fully covered is not designed, or has any engineering testing to support paediatric use, and is therefore unknown how it will function outside of it¿s intended target population of adult patients.It is possible that the size of the stent may have been too large for the patients anatomy which could have led to the stent erosion of the esophagus.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient experienced esophageal erosion causing subsequent haemorrhage due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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