MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Perforation (2001); Pneumonia (2011); Obstruction/Occlusion (2422); Post Traumatic Wound Infection (2447); Rectal Anastomotic Leakage (4482)

Event Date 09/08/2017

Event Type  Injury  

Event Description

Kit-man ho, 2017 ¿ colonic self-expanding metal stent (sems) as a bridge to surgery in left-sided malignant colonic obstruction: an 8-year review.We used through-the-scope stenting with niti-s uncovered colorectal stents (taewoong medical) in 58 patients, while colonic controlled-release stents (cook medical evolution) were used in the remaining four patients.Under fluoroscopic guidance.Fluoroscopy was available in the endoscopy suite during office hours.The procedure was performed by three colorectal surgeons who were experienced with stenting.A routine abdominal x-ray was taken 24 h after the intervention.Patients who consented to colonic stenting when fluoroscopy was available comprised the stenting group.Clinical success was defined as the resolution of obstructive symptoms within 72 h after the procedure with passage of stool [10].Upon resolution of the intestinal obstruction, patients underwent optimization of their medical condition and thorough oncological workup, including a ct scan of the thorax, abdomen and pelvis if these had not been performed before stenting.Multiple ae's described which could have potentially been associated with cook device however not confirmed: pneumonia (2), ileus (1), recurrent intestinal obstruction requiring operation (2), anastomotic leakage (2), abdominal collections (2), stent perforations (5), one patient did not have resolution of the obstructive symptoms even after successful stent deployment (stent occlusion) (1).

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted due to clinical input received on 09-jan-24 which has determined some ae's previously reported under (emdr # 3001845648-2024-00020) were not caused / contributed to by the cook device.As per clinical input on 09-jan-24, the following were deemed to be a 'complication after surgery.And irrelevant to stent placement and stent indwelling': pneumonia (2), ileus (1), recurrent intestinal obstruction requiring operation (2), anastomotic leakage (2), abdominal collections (2).The description of the event will now only capture the following having been potentially caused / contributed to by the device: five stent perforations (5), one patient did not have resolution of the obstructive symptoms even after successful stent deployment.(1).Updated description of event and updates to annex e codes: kit-man ho, 2017 ¿ colonic self-expanding metal stent (sems) as a bridge to surgery in left-sided malignant colonic obstruction: an 8-year review.We used through-the-scope stenting with niti-s uncovered colorectal stents (taewoong medical) in 58 patients, while colonic controlled-release stents (cook medical evolution) were used in the remaining four patients.Under fluoroscopic guidance.Fluoroscopy was available in the endoscopy suite during office hours.The procedure was performed by three colorectal surgeons who were experienced with stenting.A routine abdominal x-ray was taken 24 h after the intervention.Patients who consented to colonic stenting when fluoroscopy was available comprised the stenting group.Clinical success was defined as the resolution of obstructive symptoms within 72 h after the procedure with passage of stool [10].Upon resolution of the intestinal obstruction, patients underwent optimization of their medical condition and thorough oncological workup, including a ct scan of the thorax, abdomen and pelvis if these had not been performed before stenting.Two ae's described which could have potentially been associated with cook device however not confirmed: stent perforations (5) one patient did not have resolution of the obstructive symptoms even after successful stent deployment (stent occlusion) (1).

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• 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: 18455484
• MDR Text Key: 332203916
• Report Number: 3001845648-2024-00020
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/08/2017
• Event Location: Hospital
• Date Manufacturer Received: 12/08/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male