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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/28/2022

Event Type  Injury  

Event Description

(b)(6), 2022 ¿ efficacy and safety of self-expandable metal stent placement for treatment of primary and metastatic gastric outlet obstruction.The data of 42 patients with goo who received sems from november 2016 to april 2022 were reviewed retrospectively.Patients were divided into primary group (n = 25) and metastatic group (n = 17) according to the cause of goo.The rates of technical and clinical success, stent patency, and complications were compared between the two groups.The body diameter and flare of cook evolution duodenal stent (cook medical, limerick, ireland) was 22 mm and 27 mm, and length varied from 6, 9, to 12 cm.A 0.90-mm-wide, 150-cmlong terumo guide wire (terumo corporation, tokyo, japan); a 5-french dav catheter (cook medical, bloomington, in, usa); an 8-french guiding catheter (boston scientific, marlborough, ma, usa); a 0.035-in-wide, 450-cm-long zebra guidewire (boston scientific, natick, ma, usa); a 10-french, 240-cm long nasojejunal tube (wilson-cook medical, usa); liquid paraffin oil; and ge flat-panel digital subtraction angiography system (innova3100) were used.Stent malfuction: primary group - during follow-up, two (8.0%) patients had recurrence of obstruction due to tumor ingrowth or overgrowth for more than 3 months.Stent occlusion was treated by placing a second stent in two patients.Metastatic group - during follow-up, three patients had recurrence of obstruction due to tumor progression after sems implantation, including tumor overgrowth (n = 2) and ingrowth (n = 1).Stent occlusions were treated successfully by replacing stents in two patients; however, another stent failed due to complete bowel occlusion.Please note as per clinical input - placement of evo-duodenal stent without endoscopic procedure is off-label use.The stent placement procedure was off-label.Require intervention/additional procedures.A total of 42 patients were included in this study.The patients comprised 28 (66.7%) males and 14 (33.3%) females, with a mean age of 57.1 ± 12.7 (29.0¿82.0) years.

Manufacturer Narrative

510k # - k163468.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

510k#: 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 product manager has confirmed the placement of evo b without endoscopy is considered use error and not off label.Haiyang lai, 2022 ¿ efficacy and safety of self-expandable metal stent placement for treatment of primary and metastatic gastric outlet obstruction.The data of 42 patients with goo who received sems from november 2016 to april 2022 were reviewed retrospectively.Patients were divided into primary group (n = 25) and metastatic group (n = 17) according to the cause of goo.The rates of technical and clinical success, stent patency, and complications were compared between the two groups.The body diameter and flare of cook evolution duodenal stent (cook medical, limerick, ireland) was 22 mm and 27 mm, and length varied from 6, 9, to 12 cm.A 0.90-mm-wide, 150-cmlong terumo guide wire (terumo corporation, tokyo, japan); a 5-french dav catheter (cook medical, bloomington, in, usa); an 8-french guiding catheter (boston scientific, marlborough, ma, usa); a 0.035-in-wide, 450-cm-long zebra guidewire (boston scientific, natick, ma, usa); a 10-french, 240-cm long nasojejunal tube (wilson-cook medical, usa); liquid paraffin oil; and ge flat-panel digital subtraction angiography system (innova3100) were used.Stent malfunction: primary group - during follow-up, two (8.0%) patients had recurrence of obstruction due to tumor ingrowth or overgrowth for more than 3 months.Stent occlusion was treated by placing a second stent in two patients.Metastatic group - during follow-up, three patients had recurrence of obstruction due to tumor progression after sems implantation, including tumor overgrowth (n = 2) and ingrowth (n = 1).Stent occlusions were treated successfully by replacing stents in two patients; however, another stent failed due to complete bowel occlusion.Please note as per clinical input - placement of evo-duodenal stent without endoscopic procedure is user error.The stent placement procedure was off-label.Require intervention/additional procedures.A total of 42 patients were included in this study.The patients comprised 28 (66.7%) males and 14 (33.3%) females, with a mean age of 57.1 ± 12.7 (29.0¿82.0) years.

Manufacturer Narrative

Pma510k # - k163468.Device evaluation: the 05 x evolution duodenal stent system devices of unknown rpn and lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to journal article ¿lai 2022 - efficacy and safety of self-expandable metal stent placement for treatment of primary and metastatic gastric outlet obstruction¿ to capture ¿tumour ingrowth/overgrowth¿ the following were also raised in response to this journal article: 385309 - lai 2022 - patients received chemotherapy after sems placement / mdr ref#3001845648-2023-00025.385310 - lai 2022 ¿ fever and infection / mdr ref#3001845648-2023-00026.385311 - lai 2022 ¿ abdominal pain/ mdr ref# 3001845648-2023-00017.396414 - lai 2022¿ user error: placement of devices without endoscopic procedure/ mdr ref#3001845648-2023-00418.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Instructions for use and/label review: as per the ifu (ifu0053), tumour ingrowth or overgrowth is a known potential adverse event associated with gi endoscopy ¿additional complications include, but are not limited to: pancreatitis, intestinal perforation, pain, inadequate expansion, stent misplacement and/or migration, tumour ingrowth or overgrowth, stent occlusion, ulcerations, pressure necrosis, erosion of the luminal mucosa, septicaemia, foreign body sensation, bowel impaction, death (other than due to normal disease progression).¿ there is evidence to suggest that the customer did not follow the instructions for use.Pr 396414 was opened to capture the use error for the lack of an endoscopic procedure in the literature study.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to known procedural adverse events associated with the use of gi endoscopy on the patient.As stated above, tumour ingrowth or overgrowth is a known potential ae as per the instruction for use provided with the device.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the initial reporter, the patients did experience an adverse effect due to this occurrence.As per the journal article, during follow up in the primary group patients had recurrence of obstruction due to tumor ingrowth or overgrowth for more than 3 months.During follow up in the metastatic group three patients had recurrence of obstruction due to tumor progression after sems implantation, including tumor overgrowth (n = 2) and ingrowth (n = 1).Stent occlusions were treated successfully by replacing stents in two patients; however, another stent failed due to complete bowel occlusion.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 on 13-oct-2023.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16156395
• MDR Text Key: 307260688
• Report Number: 3001845648-2023-00018
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2023

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/28/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 12/15/2022; 12/15/2022
• Supplement Dates FDA Received: 05/25/2023; 11/09/2023
• 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