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

Model Number G48025

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problems Obstruction/Occlusion (2422); No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2020

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

Uncut ting of the duodenal prosthesis, requiring a chang.E product available (once the dr is back to work).Event happened (b)(6) (no exact date)."as per complaint form" customer made an examination control of duodenal stent position with gastroscope and discovered duodenal stent uncut ting requiring it replacement by a new one.This is the second time in two month that customer is confronted with the same problem.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence patient/event info - notes: was the directional button fully engaged? not concerned.Did the red indicator move when the trigger was pressed? nc.Did the red indicator continue to move after the delivery stopped? nc.Were any cracking/popping sounds heard from the handle? nc.Was the stent partially exposed? nc.If the stent was partially exposed, was it possible to recapture the stent fully before removal? nc.Were any additional procedures needed? nc.What is the patient outcome? nc.Can i confirm with you that this device will be returning to cirl for evaluation? if so, has it been shipped as of yet / is any tracking information available? i will ask.Can you please provide the following information requested below? prefix: evo.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, while removing the introducer, or during stent repositioning/removal) during stent position control.What endoscope type and channel size was used? i will ask.What was the position of the elevator? was it opened or closed? i will ask.Details of the wire guide used (diameter, type, make)? i will ask.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? it seems no.How long was the stent in the patient by the time this complaint occurred? i will ask.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? is the patient known to be covid-19 positive? i will ask.Stricture information: what was the length and diameter of the stricture? i will ask.Where was the stricture located in the body i will ask.Was there resistance felt passing wire guide through stricture? i will ask.Was there resistance felt passing the evolution through stricture? i will ask.Was the stricture dilated before stent placement i will ask.Questions related to during insertion into patient: was the product inspected for kinks or damage before use? i will ask.Was resistance felt during insertion into patient? if yes, at what point? i will ask.Questions related to during stent placement not concerned: did the product fail during stent deployment or recapture? was the directional button pressed during use? was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? was the yellow marker kept in view during deployment? are images of the device or procedure available? questions related to during introducer withdrawal: i will ask; 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? are images of the device or procedure available? questions related to during stent repositioning/removal: i will ask; what instrument was used for stent repositioning / removal? forceps, snare.Was the lasso (suture) loop used during reposi?.

Event Description

Implant date updated (b)(6) 2020.

Manufacturer Narrative

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

Event Description

Additional information was received on 20-oct-2020 describing the device 'unravelling' along with photos.Further additional information was received on 04-nov-2020, indicating that the stent was initially placed in (b)(6) 2019 and a control examination was performed in (b)(6) 2020 following which it was noted that there was a requirement to change the device, this confirms that there was no issue with the safety wire of the device.Previously reported info: uncut ting of the duodenal prosthesis, requiring a change.Product available (once the dr is back to work).Event happened mid-june (no exact date)."as per complaint form" customer made an examination control of duodenal stent position with gastroscope and discovered duodenal stent uncut ting requiring it replacement by a new one.This is the second time in two month that customer is confronted with the same problem.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Patient/event info - notes: 1.Was the directional button fully engaged? not concerned.2.Did the red indicator move when the trigger was pressed? nc.3.Did the red indicator continue to move after the delivery stopped?nc.4.Were any cracking/popping sounds heard from the handle?nc.5.Was the stent partially exposed?nc.6.If the stent was partially exposed, was it possible to recapture the stent fully before removal?nc.7.Were any additional procedures needed?nc.8.What is the patient outcome? nc.Can i confirm with you that this device will be returning to cirl for evaluation? if so, has it been shipped as of yet / is any tracking information available? i will ask.Can you please provide the following information requested below? prefix: evo 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) during stent position control.2.What endoscope type and channel size was used? i will ask.3.What was the position of the elevator? was it opened or closed? i will ask.4.Details of the wire guide used (diameter, type, make)? i will ask.5.Did any part of the stent contact the patient¿s anatomy when the complaint occurred? it seems no.6.How long was the stent in the patient by the time this complaint occurred? i will ask.7.For devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? 8.Is the patient known to be covid-19 positive? i will ask.Stricture information: 1.What was the length and diameter of the stricture? i will ask.2.Where was the stricture located in the body? i will ask.3.Was there resistance felt passing wire guide through stricture? i will ask.4.Was there resistance felt passing the evolution through stricture? i will ask.5.Was the stricture dilated before stent placement? i will ask.Questions related to during insertion into patient: 1.Was the product inspected for kinks or damage before use? i will ask.2.Was resistance felt during insertion into patient? if yes, at what point? i will ask.Questions related to during stent placement not concerned: 1.Did the product fail during stent deployment or recapture? 2.Was the directional button pressed during use? 3.Was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? 4.Was the yellow marker kept in view during deployment? 5.Are images of the device or procedure available? questions related to during introducer withdrawal: i will ask.1.Was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? 2.Did the stent open sufficiently to allow withdrawal of introducer safely? 3.Was the safety wire fully removed before removing the delivery system? 4.Did any part of the product snag/get caught with the stent when removing the delivery system? 5.Are images of the device or procedure available? questions related to during stent repositioning/removal: i will ask.1.What instrument was used for stent repositioning / removal? forceps, snare¿ was the lasso (suture) loop used during reposi.

Manufacturer Narrative

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 the completion of the investigation.

Manufacturer Narrative

Pma/510(k) #: k163468.This file is related to complaint file (b)(4), second incident reported.Device evaluation: the evo-22-27-6-d device of lot number c1620474 was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.From additional information provided, "for me pictures are very very clear !crowns broken".Therefore further clarification was requested to identify the images.Documents review including ifu review: prior to distribution all evo-22-27-6-d devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.(d00059776 (qsi0975) rev 031, d00052106 (prd0281) rev 015, d00055312 (fqc0172)rev 015).A review of the manufacturing records for evo-22-27-6-d device of lot number c1620474 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 #c1620474; upon review of complaints this failure mode has not occurred previously with this lot #c1620474.As per 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", "additional complication include, but are not limited to: stent occlusion." on review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Additional information: further imaging was received from the hospital and there were traceability concerns regarding these images.It was difficult to distinguish what images were associated with the 4 complaints opened related to this customer (b)(4).This affected the ability of cook to investigate the issue.Several attempts were made to communicate with the customer however information received did not assist with the traceability issue or the root cause determination for the complaint.Pictures).Msg").Based on the images provided although it cannot be confirmed which one is associated with (b)(4) it is more likely that stent fracture occurred.Therefore the complaint investigation will be done on stent fracture.Cook research inc.(cri) input was provided "due to the lack the event description and lack of image traceability we are not able to provide an image review on this imaging provided.There just isn¿t enough information provided to link these images to (b)(4).Therefore if traceability of the images becomes available the investigation will be updated accordingly.As per medical advisor, "this stent is to treat strictures caused by malignant neoplasms, and it cannot be removed or repositioned after deployment, so the implantation period should be permanent until patient expires.Due to the aggressive nature of the malignant neoplasms, the definition ¿permanent¿ here is relatively short e.G., for weeks or months.However, the patient life expectancy has been significantly increased nowadays (e.G., years) with adjuvant therapies especially immunotherapy, which might have contributed to the longer indwelling of the stent in patient, thus increased the risk of stent fracture." root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to was that the tumor ingrowth or overgrowth and the longer survival time could have contributed to this stent fracture.(ref.Att."re: (b)(4)medical advisor input required").Summary: customer complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.However, as per additional information provided, "uncut ting of the duodenal prosthesis, requiring a change"? yes by a new one from boston scientific.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Pma/510(k) #: k163468.This file is related to complaint file pr 300445 (3001845648-2020-00356), second incident reported.Device evaluation: the evo-22-27-6-d device of lot number c1620474 was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.From additional information provided, "for me pictures are very very clear !crowns broken".Therefore further clarification was requested to identify the images.Documents review including ifu review: prior to distribution all evo-22-27-6-d devices are subject to 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-22-27-6-d device of lot number c1620474 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 #c1620474; upon review of complaints this failure mode has not occurred previously with this lot #c1620474.As per 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", "additional complication include, but are not limited to: stent occlusion" as per precautions sections ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding.Long-term patency of this device has not been established¿ for these devices.On review of the information provided, there is evidence to suggest that the user did not follow the instructions for use.From additional information provided "adjuvant chemotherapy and conformational radiotherapy treatment (january 2019).Prolonged survival, still alive ".Additional information: further imaging was received from the hospital and there were traceability concerns regarding these images.It was difficult to distinguish what images were associated with the 4 complaints opened related to this customer.This affected the ability of cook to investigate the issue.Several attempts were made to communicate with the customer however information received did not assist with the traceability issue or the root cause determination for the complaint.Based on the images provided although it cannot be confirmed which one is associated with pr305945 it is more likely that stent fracture occurred.Therefore the complaint investigation will be done on stent fracture.Cook research inc.(cri) input was provided "due to the lack the event description and lack of image traceability we are not able to provide an image review on this imaging provided.There just isn¿t enough information provided to link these images to pr 305945.Therefore if traceability of the images becomes available the investigation will be updated accordingly.As per medical advisor, "this stent is to treat strictures caused by malignant neoplasms, and it cannot be removed or repositioned after deployment, so the implantation period should be permanent until patient expires.Due to the aggressive nature of the malignant neoplasms, the definition ¿permanent¿ here is relatively short e.G., for weeks or months.However, the patient life expectancy has been significantly increased nowadays (e.G., years) with adjuvant therapies especially immunotherapy, which might have contributed to the longer indwelling of the stent in patient, thus increased the risk of stent fracture." root cause review: a definitive root cause could be determined from the available information.A definitive root cause can be attributed to user error as the chemotherapy and radiotherapy should not be used after stent placement, therefore the user did not follow the instructions for use.As per the instructions for use, ifu0053-10, which accompanies this device, as per precautions sections ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding.Long-term patency of this device has not been established¿ for these devices.From additional information provided "adjuvant chemotherapy and conformational radiotherapy treatment (january 2019).Prolonged survival, still alive." summary: customer complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.However, as per additional information provided, "uncut ting of the duodenal prosthesis, requiring a change"? yes by a new one from boston scientific.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: 10480015
• MDR Text Key: 244362294
• Report Number: 3001845648-2020-00534
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480251
• UDI-Public: (01)10827002480251(17)210607(10)C1620474
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 10/18/2021

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: 06/07/2021
• Device Model Number: G48025
• Device Catalogue Number: EVO-22-27-6-D
• Device Lot Number: C1620474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 08/05/2020; 08/05/2020; 08/05/2020; 08/05/2020
• Supplement Dates FDA Received: 11/18/2020; 12/16/2020; 03/26/2021; 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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
• Patient Sex: Male