MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48027

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Per rep - (b)(6) 2020 - the device did not deploy as expected.Per customer - (b)(6) 2020 - after putting the tome down the scope, the cutting wire on the sphincterotome broke when the tome was flexed.Patient outcome: the customer has been asked to provide the answers to the following questions.Did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.Patient/event info - notes: the customer has been asked to provide the answers to the following questions.General questions: at what stage of the procedure did the complaint occur? at the end of the procedure.When unpacking or preparing the evolution, while inserting the evolution in the patient, during stent placement, while removing the introducer, during stent repositioning/removal, what endoscope type and channel size was used? what was the position of the elevator? was it opened or closed? details of the wire guide used (diameter, type, make)? did any part of the stent contact the patient¿s anatomy when the complaint occurred? how long was the stent in the patient by the time this complaint occurred? for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? stricture information: what was the length of the diameter of the stricture? where was the stricture located in the body? was there resistance felt passing the wire guide through stricture? was there resistance felt passing the evolution through stricture? was the stricture dilated before stent placement? no.Questions related to during insertion into patient: was the product inspected for kinks or damage before use? was resistance felt during insertion into patient? if yes, at what point? questions related to during stent placement: did the product fail during stent deployment or recapture? yes.Was the directional button pressed during use? yes.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? yes.Was the yellow marker kept in view during deployment? yes.Are images of the device or procedure available? no.Questions related to during introducer withdrawal: was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? did the stent open sufficiently to allow withdrawal of introducer safely? was the safety wire fully removed before removing the delivery system? did any part of the product snag/get caught with the stent when removing the delivery system? yes.Are images of the device or procedure available? no.Questions related to during stent repositioning/removal: what instrument was used for stent repositioning/removal? forceps, snare¿ none.Was the lasso (suture) loop used during repositioning / removal? no.

Manufacturer Narrative

Pma/510(k) #: k163468.Device evaluation: the evo-22-27-12-d device of lot number c1518222 involved in this complaint was not returned for evaluation.With the information provided, a document based investigation was conducted.Documents review including ifu review: prior to distribution all evo-22-27-12-d devices 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-22-27-12-d device of lot number c1518222 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 #c1518222; upon review of complaints this failure mode has not occurred previously with this lot #c1518222.The instructions for use ifu0053-10 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.Additional information was requested to aid with the investigation to elaborate on the "the cutting wire on the sphinctertome broke when the tome was flexed.¿ from information received: "the last time i asked the customer for more information, she responded with ¿the information that was provided previously is the information that is known the rest is unknown." as per product manager, "yes cook does manufacture sphincterotomes (cook endoscopy/winston salem) but not cook ireland".Additional information was requested to address the sphincterotome issue.Due to the current circumstances and restrictions regarding covid-19, only one attempt for additional information has been made.As this information has not yet been confirmed, it is assumed that the complaint registered is with the evolution device and as there is no information to indicate that the sphincterotome mentioned is a cook device no additional file will be raised in relation to this, if further clarification is received investigation will be updated.Root cause review: a possible root cause could be that the stent got caught on the delivery system on removal or possibly that the stent failed to deploy fully out of the delivery system.From the provided information it is known that the stricture was not dilated before the stent placement, due to this it may be possible that the difficulties encountered could be attributed to compression from patient anatomy, possibly resulting in the inability to fully deploy the stent which will be assessed for risk as best assumption.However, as the device was not returned for evaluation & due to limited information; the cause of this complaint could not be conclusively determined.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Customer complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Per rep - (b)(6) 2020 - the device did not deploy as expected.Per customer - (b)(6) 2020 - after putting the tome down the scope, the cutting wire on the sphinctertome broke when the tome was flexed.Patient outcome: the customer has been asked to provide the answers to the following questions.Did any unintended section of the device remain inside the patient¿s body? -no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? -no.Did the patient require any additional procedures due to this occurrence? -no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? -no.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? -no.Has the complainant reported that the product caused or contributed to the adverse effects? -no.Please specify adverse effects and provide details.Patient/event info - notes: the customer has been asked to provide the answers to the following questions.1.1 general questions: 1.1.1 at what stage of the procedure did the complaint occur? at the end of the procedure.When unpacking or preparing the evolution.While inserting the evolution in the patient.During stent placement while removing the introducer.During stent repositioning/removal.1.1.2 what endoscope type and channel size was used? 1.1.3 what was the position of the elevator? was it opened or closed? 1.1.4 details of the wire guide used (diameter, type, make)? 1.1.5 did any part of the stent contact the patient¿s anatomy when the complaint occurred? 1.1.6 how long was the stent in the patient by the time this complaint occurred? 1.1.7 for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? 1.2 stricture information: 1.2.1 what was the length of the diameter of the stricture? 1.2.2 where was the stricture located in the body? 1.2.3 was there resistance felt passing the wire guide through stricture? 1.2.4 was there resistance felt passing the evolution through stricture? 1.2.5 was the stricture dilated before stent placement? no.1.3 questions related to during insertion into patient.1.3.1 was the product inspected for kinks or damage before use? 1.3.2 was resistance felt during insertion into patient? if yes, at what point? 1.4 questions related to during stent placement 1.4.1 did the product fail during stent deployment or recapture? yes 1.4.2 was the directional button pressed during use? yes 1.4.3 was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? yes.1.4.4 was the yellow marker kept in view during deployment? yes.1.4.5 are images of the device or procedure available? no.1.5 questions related to during introducer withdrawal.1.5.1 was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? 1.5.2 did the stent open sufficiently to allow withdrawal of introducer safely? 1.5.3 was the safety wire fully removed before removing the delivery system? 1.5.4 did any part of the product snag/get caught with the stent when removing the delivery system? yes 1.5.5 are images of the device or procedure available? no.1.6 questions related to during stent repositioning/removal.1.6.1 what instrument was used for stent repositioning/removal? forceps, snare none.1.6.2 was the lasso (suture) loop used during repositioning / removal? no.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10165230
• MDR Text Key: 242646070
• Report Number: 3001845648-2020-00357
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480275
• UDI-Public: (01)10827002480275(17)200709(10)C1518222
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/09/2020
• Device Model Number: G48027
• Device Catalogue Number: EVO-22-27-12-D
• Device Lot Number: C1518222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/08/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 05/22/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1