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COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL
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| Model Number G48033 |
| Device Problems
Structural Problem (2506); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
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| Patient Problems
Obstruction/Occlusion (2422); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/13/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) #: (b)(4).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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Updated as per the completed complaint form received: dilation and guide wire was in place and the gastroenerologist ((b)(4)) ask for the stent.The red safety guard was removed but on the first two squeezes of the trigger action, a large "crushing noise" was heard, the physician ask to continue and the stent was deployed and the safety wire removed but the introduction system could not be removed and when the doctor try to remove it, the whole stent came out with the system.The procedure was terminated and we received a call from the hospital to have a new stent sent which we did and the new stent was safely deployed this afternoon ((b)(6) 2021) with the support of a local cook territory manager and sales manager.As per the rep's email, an email was received yesterday from gosford public hospital with a complaint regarding the deployment of a cook evolution esophageal stent.Further details was requested from the rep on 13 jan 21, however, he won't be able to provide this until friday.
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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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Device evaluated on 19-feb-21: "peek tubing kinked.Coq broken".Previously reported: updated as per the completed complaint form received: dilation and guide wire was in place and the gastroenerologist (dr (b)(6) ) ask for the stent.The red safety guard was removed but on the first two squeezes of the trigger action, a large "crushing noise" was heard, the physician ask to continue and the stent was deployed and the safety wire removed but the introduction system could not be removed and when the doctor try to remove it, the whole stent came out with the system.The procedure was terminated and we received a call from the hospital to have a new stent sent which we did and the new stent was safely deployed this afternoon ((b)(6) 2021) with the support of a local cook territory manager and sales manager.As per the rep's email, an email was received yesterday from gosford public hospital with a complaint regarding the deployment of a cook evolution esophageal stent.Further details was requested from the rep on 13 jan 21, however, he won't be able to provide this until friday.
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Event Description
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Supplemental report being submitted due to the investigation being completed on 12-may-2021.Updated as per the completed complaint form received: dilation and guide wire was in place and the gastroenerologist (dr (b)(6)) ask for the stent.The red safety guard was removed but on the first two squeezes of the trigger action, a large "crushing noise" was heard, the physician ask to continue and the stent was deployed and the safety wire removed but the introduction system could not be removed and when the doctor try to remove it, the whole stent came out with the system.The procedure was terminated and we received a call from the hospital to have a new stent sent which we did and the new stent was safely deployed this afternoon (friday (b)(6) 2021) with the support of a local cook territory manager and sales manager.As per the rep's email, an email was received yesterday from (b)(6) hospital with a complaint regarding the deployment of a cook evolution esophageal stent.Further details was requested from the rep on 13 jan 21, however, he won't be able to provide this until friday.No unintended part of the device remained inside the patient's body.The procedure that was started on (b)(6) 2021 was terminated.A new stent was safely deployed on (b)(6) 2021.No adverse effect on the patient due to this occurrence was reported.General questions: 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? after the stent position fluoroscopically, when the nurse removed the red safety guard and started to squeeze the trigger (make crunching noises).2.What endoscope type and channel size was used? 3.What was the position of the elevator? don¿t know.4.Details of the wire guide used (diameter, type, make)? don¿t know.5.Was the zip port facing upwards and slightly curved when backloading the wire guide? no.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.Esophageas.8.How long was the stent in the patient by the time this complaint occurred? don¿t know.9.For devices where the ifu states for longer term patency has not been established, was periodic evaluation completed? n/a.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? new evolution stent procedure few days later.13.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? another day.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.Stricture information: 1.What was the length and diameter of the stricture? 9cm.2.Where was the stricture located in the body? esophageas.3.Was there resistance felt passing wire guide through stricture? no.4.Was there resistance felt passing the evolution through stricture? no.5.Was the stricture dilated before stent placement? don¿t know.Questions related to during insertion into patient: 1.Was the product inspected for kinks or damage before use? yes.2.Was resistance felt during insertion into patient? no.3.If yes, at what point? questions related to during stent placement: 1.Did the product fail during stent deployment or recapture? deployment.2.If other, please specify.3.Was the directional button pressed during use? yes (according to the nurse).4.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? yes.5.Was the yellow marker kept in view during deployment? n/a.6.Are images of the device or procedure available? no.Questions related to during introducer withdrawal: 1.Are images of the device or procedure available? no.2.Was final stent placement confirmed using endoscopy / fluoroscopy? yes.3.If yes, what was used? fluro.4.Did the stent open sufficiently to allow withdrawal of introducer safely? yes.5.Was the safety wire fully removed before removing the delivery system? yes.6.Did any part of the product snag/get caught with the stent when removing the delivery system? no.
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Manufacturer Narrative
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Pma/510(k) #: k162717.Device evaluation: the evo-20-25-15-e devices of lot number c1609422 involved in this complaint device was returned for evaluation, open in its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 19th february 2021.The returned device lab findings and observations can be referred through the files.In summary the following results were observed in the lab evaluation: device 1: stent was not returned.Red marker on top of the introducer passed the point of no return.Kink observed on peek tubing.Handle was actuating with slight resistance and "crushing noise" was heard.Handle was opened and broken cog was observed.All other components were intact.Device 2.Device was returned unused in the sealed packaging.Handle was actuating fine.Stent deployed without any issues.Lock wire was removed without any issues.Device functioned as intended.Following the lab evaluation an additional information was requested to aid with this investigation, as per additional information provided: "as per rep, unfortunately, the stent was discarded by the nurse after it was removed from the patient.Jil01 (b)(6) 2021" documents review including ifu review: prior to distribution all evo-20-25-15-edevices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-20-25-15-e device of lot number c1609422 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1609422; upon review of complaints this failure mode has not occurred previously with this lot #c1609422.The instructions for use ifu0061-5 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use.As per medical advisor "i cannot find the information of requirement of surgery in the below.Another stent was placed in a rescheduled procedure will be consider as a re-intervention but not ¿surgery¿ and the severity is +4.I agree that the rescheduled procedure would not have been required to prevent permanent impairment/damage." root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause may be attributed to tortuous anatomy which may have caused kinking in the peek tubing, thereafter is likely the kinked tubing caused a build-up of pressure and potentially caused the cog to break.Summary: according to the initial reporter, no adverse effect on the patient due to this occurrence was reported.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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This supplemental report is being submitted as a correction to the e and f imdrf codes and the investigation conclusions on the (b)(6) 2023.
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Manufacturer Narrative
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Pma/510(k) #: k162717 device evaluation: the evo-20-25-15-e devices of lot number c1609422 involved in this complaint device was returned for evaluation, open in its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2021.The returned device lab findings and observations can be referred through the attached files.In summary the following results were observed in the lab evaluation: device 1: stent was not returned.Red marker on top of the introducer passed the point of no return.Kink observed on peek tubing.Handle was actuating with slight resistance and "crushing noise" was heard.Handle was opened and broken cog was observed.All other components were intact.Device 2.Device was returned unused in the sealed packaging.Handle was actuating fine.Stent deployed without any issues.Lock wire was removed without any issues.Device functioned as intended.Following the lab evaluation an additional information was requested to aid with this investigation, as per additional information provided: "as per rep, unfortunately, the stent was discarded by the nurse after it was removed from the patient.Jil01 (b)(6) 2021".Documents review including ifu review: prior to distribution all evo-20-25-15-edevices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-20-25-15-e device of lot number c1609422 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1609422; upon review of complaints this failure mode has not occurred previously with this lot #c1609422.The instructions for use ifu0061-5 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.As per medical advisor "i cannot find the information of requirement of surgery in the below.Another stent was placed in a rescheduled procedure will be consider as a re-intervention but not ¿surgery¿ and the severity is +4.I agree that the rescheduled procedure would not have been required to prevent permanent impairment/damage." root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause may be attributed to tortuous anatomy which may have caused kinking in the peek tubing, thereafter is likely the kinked tubing caused a build-up of pressure and potentially caused the cog to break.Summary: according to the initial reporter, no adverse effect on the patient due to this occurrence was reported.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
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Manufacturer Narrative
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Pma/510(k) #(b)(4).Device evaluation: the evo-20-25-15-e devices of lot number c1609422 involved in this complaint device was returned for evaluation, open in its original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2021.The returned device lab findings and observations can be referred through the attached files.In summary the following results were observed in the lab evaluation: device 1: stent was not returned.Red marker on top of the introducer passed the point of no return.Kink observed on peek tubing.Handle was actuating with slight resistance and "crushing noise" was heard.Handle was opened and broken cog was observed.All other components were intact.Device 2.Device was returned unused in the sealed packaging.Handle was actuating fine.Stent deployed without any issues.Lock wire was removed without any issues.Device functioned as intended.Following the lab evaluation an additional information was requested to aid with this investigation, as per additional information provided: "as per rep, unfortunately, the stent was discarded by the nurse after it was removed from the patient.Jil01 (b)(6) 2021".Documents review including ifu review: prior to distribution all evo-20-25-15-edevices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-20-25-15-e device of lot number c1609422 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1609422; upon review of complaints this failure mode has not occurred previously with this lot #c1609422.The instructions for use ifu0061-5 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a as per medical advisor "i cannot find the information of requirement of surgery in the below.Another stent was placed in a rescheduled procedure will be consider as a re-intervention but not ¿surgery¿ and the severity is +4.I agree that the rescheduled procedure would not have been required to prevent permanent impairment/damage." root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause may be attributed to tortuous anatomy which may have caused kinking in the peek tubing, thereafter is likely the kinked tubing caused a build-up of pressure and potentially caused the cog to break.Summary: according to the initial reporter, no adverse effect on the patient due to this occurrence was reported.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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This supplemental report is being submitted as a correction to the imdrf codes changing f-code from: f1901 ¿ additional surgery to f2202 ¿ endoscopic diagnostic procedure on the 08-jan-2024.
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