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

Model Number G48025

Device Problems Partial Blockage (1065); Fracture (1260); Off-Label Use (1494)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 08/27/2020

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

This file relates to fda mdr report reference numbers - 3001845648-2020-00415 and 3001845648-2020-00534.Dr implanted this stent the (b)(6) 2018 and patient came back to hospital in (b)(6) 2020 ( 2 years later) for a control examination because stent seemed clogged.Dr made examination for controlling duodenal stent and she discovered proximal stent parts totally broken and clogged.Pb is not only the first time with this customer but it is the third times (pc fr 102 994 and pc fr 104 306) customer stopped to order duodenal cook stent since last (b)(6) and will not recommend duodenal cook stent for the next tender next year.This a very bad news, we sold to aphp (public hospitals of (b)(6)) 300 evo d from (b)(6) 2019, 120k¿ per year ! i need a strong support for this situation, dr doesn¿t speak english but she accepted to reply to our questions if they are translated.Do we have statistics, studies etc for limited negative impact of this situation.

Event Description

This file relates to fda mdr report reference numbers - 3001845648-2020-00415 and 3001845648-2020-00534.Supplemental report is being submitted to correct an error with the categorization of the report.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) #: k163468.Lab evaluation: the evo-22-27-6-d device of lot number c1483724 was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.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 c1483724 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 #c1483724 ; upon review of complaints this failure mode has not occurred previously with this lot #c1483724.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 evidence to suggest that the user did not follow the instructions for use.As per images provided endoscopic clip was placed, this would be considered off label use.As per medical advisor input "i am not sure if the physician might have used the clip to prevent stent migration, but it is definitely not a part of procedure for duodenal stent placement, it is not stated in our ifu and it is off-label use in conjunction with our stent.The clip might have been used for other purposes that i wouldn¿t know." image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: for imaging review reference the attached.It may be noted that the an image review was performed based on the first image received on the file.Impression: "fracture of a stent consistent with an evo duodenal stent is confirmed." 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.Additional information was provided and it appears to be related to complaint file (b)(4), as it was indicated that the answers provided are regarding a case where stent placement occurred on the (b)(6) 2018.: "here are my answers regarding this case.Duodenal prosthesis placed on (b)(6) 2018.1 / i don't know what this image corresponds to (87 years old).2 / resectable pancreatic cancer but not done because of the patient's age 3 / adjuvant chemotherapy and conformational radiotherapy treatment ((b)(6) 2019).Prolonged survival, still alive.4 / no complications from adjuvant treatment.5 / no other duodenal prosthesis before the anomaly is noticed.6 / a biliary prosthesis was placed by appointment technique with a gastroscope on (b)(6)2018.New biliary prosthesis on (b)(6) 2019 with a duodenoscope.7 / placement of a new duodenal prosthesis on (b)(6) 2020.9 / the patient is well, consultation of (b)(6) 2012".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)(6).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.As per images provided endoscopic clip was placed, this would be considered off label use.Therefore, as the device was used off label it is ensure how the device would function therefore this could have contributed to the stent fracture.As per medical advisor input "i am not sure if the physician might have used the clip to prevent stent migration, but it is definitely not a part of procedure for duodenal stent placement, it is not stated in our ifu and it is off-label use in conjunction with our stent.The clip might have been used for other purposes that i wouldn¿t know." "as per images provided, there was a presence of unknown wire, this would be considered off label use.The evo duodenal stent has been on market for years.The stent was designed for palliative treatment which means the patient¿s survival time is limited (weeks or months).However, with adjuvant chemotherapy and conformational radiotherapy treatment nowadays, patient¿s survival time has significantly been increased, for instance this patient had had stent placed on (b)(6) 2018 for palliative treatment but is still well after more than 2 years ((b)(6) 2020?).Therefore, tumor ingrowth or overgrowth and the longer survival time could have contributed to this stent fracture.It is also possible that this device was used off label.As per images provided, there was a presence of unknown wire, this would be considered off label use." (ref.Att."re (b)(4) medical advisor and engineering input required").Summary: customer complaint is confirmed based on customer testimony.According to the initial reporter, the patient is well.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.Lab evaluation: the evo-22-27-6-d device of lot number c1483724 was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.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 c1483724 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 #c1483724 ; upon review of complaints this failure mode has not occurred previously with this lot #c1483724.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.As per images provided endoscopic clip was placed, this would be considered off label use.As per medical advisor input "i am not sure if the physician might have used the clip to prevent stent migration, but it is definitely not a part of procedure for duodenal stent placement, it is not stated in our ifu and it is off-label use in conjunction with our stent.The clip might have been used for other purposes that i wouldn¿t know.It may be noted that the chemotherapy and radiotherapy should not bae used after stent placement.From additional information provided "adjuvant chemotherapy and conformational radiotherapy treatment ((b)(6) 2019).Prolonged survival, still alive " image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: impression: "fracture of a stent consistent with an evo duodenal stent is confirmed." 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 (b)(4) complaints opened related to this customer (b)(4), (report reference number 3001845648-2020-00356), (b)(4) (report reference number 3001845648-2020-00415), (b)(4) (report reference number 3001845648-2020-00534) and (b)(4) (report reference number 3001845648-2020-00766).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.Additional information was provided and it appears to be related to complaint file (b)(4), as it was indicated that the answers provided are regarding a case where stent placement occurred on the (b)(6) 2018.: "here are my answers regarding this case duodenal prosthesis placed on (b)(6) 2018 1 / i don't know what this image corresponds to (87 years old).2 / resectable pancreatic cancer but not done because of the patient's age.3 / adjuvant chemotherapy and conformational radiotherapy treatment ((b)(6) 2019).Prolonged survival, still alive.4 / no complications from adjuvant treatment.5 / no other duodenal prosthesis before the anomaly is noticed.6 / a biliary prosthesis was placed by appointment technique with a gastroscope on (b)(6) 2018.New biliary prosthesis on (b)(6) 2019 with a duodenoscope.7 / placement of a new duodenal prosthesis on (b)(6) 2020.9 / the patient is well, consultation of (b)(6) 2012".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 be determined from the available information.As per images provided endoscopic clip was placed, this would be considered off label use.Therefore, as the device was used off label it is ensure how the device would function therefore this could have contributed to the stent fracture.As per medical advisor input "i am not sure if the physician might have used the clip to prevent stent migration, but it is definitely not a part of procedure for duodenal stent placement, it is not stated in our ifu and it is off-label use in conjunction with our stent.The clip might have been used for other purposes that i wouldn¿t know." "as per images provided, there was a presence of unknown wire, this would be considered off label use.The evo duodenal stent has been on market for years.The stent was designed for palliative treatment which means the patient¿s survival time is limited (weeks or months).However, with adjuvant chemotherapy and conformational radiotherapy treatment nowadays, patient¿s survival time has significantly been increased, for instance this patient had had stent placed on (b)(6) 2018 for palliative treatment but is still well after more than 2 years ((b)(6) 2020?).Therefore, tumor ingrowth or overgrowth and the longer survival time could have contributed to this stent fracture.It is also possible that this device was used off label.As per images provided, there was a presence of unknown wire, this would be considered off label use." summary: customer complaint is confirmed based on customer testimony.According to the initial reporter, the patient is well.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to updates made to the investigation.

Manufacturer Narrative

Pma/510(k) #: k163468.Lab evaluation: the evo-22-27-6-d device of lot number c1483724 was not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.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.A review of the manufacturing records for evo-22-27-6-d device of lot number c1483724 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 #c1483724 ; upon review of complaints this failure mode has not occurred previously with this lot #c1483724.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.As per images provided endoscopic clip was placed, this would be considered off label use.As per medical advisor input "i am not sure if the physician might have used the clip to prevent stent migration, but it is definitely not a part of procedure for duodenal stent placement, it is not stated in our ifu and it is off-label use in conjunction with our stent.The clip might have been used for other purposes that i wouldn¿t know.It may be noted that the chemotherapy and radiotherapy should not bae used after stent placement.From additional information provided "adjuvant chemotherapy and conformational radiotherapy treatment (january 2019).Prolonged survival, still alive " image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: it may be noted that the an image review was performed based on the first image received on the file.Impression: "fracture of a stent consistent with an evo duodenal stent is confirmed." 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 (b)(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.Additional information was provided and it appears to be related to complaint file (b)(4), as it was indicated that the answers provided are regarding a case where stent placement occurred on the (b)(6) 2018.: "here are my answers regarding this case.Duodenal prosthesis placed on (b)(6) 2018.1 / i don't know what this image corresponds to (87 years old).2 / resectable pancreatic cancer but not done because of the patient's age.3 / adjuvant chemotherapy and conformational radiotherapy treatment ((b)(6) 2019).Prolonged survival, still alive.4 / no complications from adjuvant treatment.5 / no other duodenal prosthesis before the anomaly is noticed.6 / a biliary prosthesis was placed by appointment technique with a gastroscope on (b)(6) 2018.New biliary prosthesis on (b)(6) 2019 with a duodenoscope.7 / placement of a new duodenal prosthesis on (b)(6) 2020.9 / the patient is well, consultation of (b)(6) 2012".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) (3001845648-2020-00534).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.As per images provided endoscopic clip was placed, this would be considered off label use.Therefore, as the device was used off label it is ensure how the device would function therefore this could have contributed to the stent fracture.As per medical advisor input "i am not sure if the physician might have used the clip to prevent stent migration, but it is definitely not a part of procedure for duodenal stent placement, it is not stated in our ifu and it is off-label use in conjunction with our stent.The clip might have been used for other purposes that i wouldn¿t know." "as per images provided, there was a presence of unknown wire, this would be considered off label use.The evo duodenal stent has been on market for years.The stent was designed for palliative treatment which means the patient¿s survival time is limited (weeks or months).However, with adjuvant chemotherapy and conformational radiotherapy treatment nowadays, patient¿s survival time has significantly been increased, for instance this patient had had stent placed on (b)(6) 2018 for palliative treatment but is still well after more than 2 years ((b)(6) 2020?).Therefore, tumor ingrowth or overgrowth and the longer survival time could have contributed to this stent fracture.It is also possible that this device was used off label.As per images provided, there was a presence of unknown wire, this would be considered off label use." summary: customer complaint is confirmed based on customer testimony.According to the initial reporter, the patient is well.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental correction report is being submitted due to amendment to the lot number documented within section d4 of previously submitted report.

• 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; o'halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 10651177
• MDR Text Key: 210486292
• Report Number: 3001845648-2020-00766
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480251
• UDI-Public: (01)10827002480251(17)200511(10)C1483724
• 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: 04/25/2022

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: 05/11/2020
• Device Model Number: G48025
• Device Catalogue Number: EVO-22-27-6-D
• Device Lot Number: C1483724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/27/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 09/10/2020; 09/10/2020; 09/10/2020
• Supplement Dates FDA Received: 12/22/2020; 03/30/2021; 11/11/2021; 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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