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

Model Number G48026

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Customer deployed stent completely, and they did pull the safety wire at the end of deploying it completely.The tech did say they only pulled the safety wire out ~4 inches, so possibly not completely.Realized that the stent wasn't fully expanding and it was still attached to the delivery system catheter.Couldn't get it dislodged from the delivery system.They pulled it back and it ended up in the stomach, where it dislodged, so they had to go back down to use an overtube to get it out of the patient.Stent observed shredded once out of the patient, but they don't know when that happened.Customer used another of the same gpn to complete procedure successfully, longer procedure but not prolonged hospitalization." patient outcome: 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 due to this occurrence? no if yes, please describe.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: general questions: 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 ***this one*** while removing the introducer during stent repositioning/removal what endoscope type and channel size was used? olympus scope, size/model unknown.What was the position of the elevator? it wasn't a scope with an elevator was it opened or closed? details of the wire guide used (diameter, type, make)? olympus clever-cut.035 did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes how long was the stent in the patient by the time this complaint occurred? during deployment--minutes? for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? n/a wasn't expanded successfully stricture information: what was the length of the diameter of the stricture? asku where was the stricture located in the body? duodenum was there resistance felt passing the wire guide through stricture? asku was there resistance felt passing the evolution through stricture? no was the stricture dilated before stent placement? asku questions related to during insertion into patient was the product inspected for kinks or damage before use? yes was resistance felt during insertion into patient? no if yes, at what point? questions related to during stent placement did the product fail during stent deployment or recapture? deployment was the directional button pressed during use? no was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? stent is in the patient, but end of the stent is still in delivery system.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? no; stent wasn't placed if yes, what was used? did the stent open sufficiently to allow withdrawal of introducer safely? no was the safety wire fully removed before removing the delivery system? tech said he pulled it out ~4 inches 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¿ overtube once device was dislodged in patient's stomach.Was the lasso (suture) loop used during repositioning / removal.Asku but dm believes no.

Event Description

Follow-up report being submitted to capture lab evaluation completed by cook ireland on 12-aug-2020.Complaint called in by dm on 01jul2020--did 01jul2020.As reported to customer relations: "customer deployed stent completely, and they did pull the safety wire at the end of deploying it completely.The tech did say they only pulled the safety wire out ~4 inches, so possibly not completely.Realized that the stent wasn't fully expanding and it was still attached to the delivery system catheter.Couldn't get it dislodged from the delivery system.They pulled it back and it ended up in the stomach, where it dislodged, so they had to go back down to use an overtube to get it out of the patient.Stent observed shredded once out of the patient, but they don't know when that happened.Customer used another of the same gpn to complete procedure successfully, longer procedure but not prolonged hospitalization." patient outcome: 1.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.3.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.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: it was indicated that it was observed ¿that the stent wasn¿t fully expanding" does this mean that the stent could not be fully deployed? yes, that is correct.1.1 general questions: 1.1.1 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,this one.While removing the introducer, during stent repositioning/removal.1.1.2 what endoscope type and channel size was used? olympus scope, size/model unknown.1.1.3 what was the position of the elevator? it wasn't a scope with an elevator.Was it opened or closed? 1.1.4 details of the wire guide used (diameter, type, make)? olympus clever-cut.035.1.1.5 did any part of the stent contact the patient¿s anatomy when the complaint occurred? yes.1.1.6 how long was the stent in the patient by the time this complaint occurred? during deployment--minutes? 1.1.7 for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? n/a.Wasn't expanded successfully.1.2 stricture information: 1.2.1 what was the length of the diameter of the stricture? asku.1.2.2 where was the stricture located in the body? duodenum.1.2.3 was there resistance felt passing the wire guide through stricture? asku.1.2.4 was there resistance felt passing the evolution through stricture? no.1.2.5 was the stricture dilated before stent placement? asku.1.3 questions related to during insertion into patient.1.3.1 was the product inspected for kinks or damage before use? yes.1.3.2 was resistance felt during insertion into patient? no.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? deployment.1.4.2 was the directional button pressed during use? no.1.4.3 was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? stent is in the patient, but end of the stent is still in delivery system.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? no; stent wasn't placed.If yes, what was used? 1.5.2 did the stent open sufficiently to allow withdrawal of introducer safely? no.1.5.3 was the safety wire fully removed before removing the delivery system? tech said he pulled it out ~4 inches.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, overtube once device was dislodged in patient's stomach.1.6.2 was the lasso (suture) loop used during repositioning / removal.Asku but dm believes no.

Manufacturer Narrative

Follow-up report being submitted to capture lab evaluation completed by cook ireland on 12-aug-2020.Pma/510(k) #: k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to completion of investigation.

Manufacturer Narrative

Pma/510(k) #: k163468.Device evaluation: the evo-22-27-9-d device of lot number c1726654 involved in this complaint device 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 involved in the complaint was evaluated in the laboratory on the (b)(6) 2020.In summary the following results were observed in the lab evaluation: the stent was fully deployed on return.Lock wire still in delivery system, removed approximately 14 inches.Button in neutral position on return.Handle actuating file for deployment and retraction.(b)(4) inch wire guide passed through with no issues.Lockwire removed without difficulty.Device functioning fine.Some of the wires on the stent were out of shape, engineering have agreed that this is likely due to removal, " the stent shape became distorted due to removal." following the lab evaluation additional information was requested to aid with the investigation; "it was indicated that it was observed ¿that the stent wasn¿t fully expanding¿¿does this mean that the stent could not be fully deployed? yes, that is correct." documents review including ifu review: prior to distribution all evo-22-27-9-d devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for evo-22-27-9-d device of lot number c1726654 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 #c1726654; upon review of complaints this failure mode has not occurred previously with this lot #c1726654.The instructions for use ifu0053-10 which accompanies this device instructs the user to "when stent point -of -no return has been passed, pull safety wire out of delivery handle near wire guide port".There is possible evidence to suggest that the customer did not follow the instructions for use.Therefore, product manager was notified to consider retraining at the facility 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 could be attributed to device may have been in torturous position not impacting deployment but potentially making it more difficult to remove lock wire.Additionally a possible root cause could be attributed to a device handling and it is possible that that the safety wire was not removed far enough and it was still connecting to stent.Therefore it is possible that once the delivery system was pulled back force likely released stent.It may be noted that some of the wires on the stent were observed out of shape during the lab evaluation, engineering have agreed that this is likely due to removal, " the stent shape became distorted due to removal." summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10340822
• MDR Text Key: 207916002
• Report Number: 3001845648-2020-00462
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)220417(10)C1726654
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2022
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1726654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 07/01/2020; 07/01/2020
• Supplement Dates FDA Received: 08/27/2020; 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention