MAUDE Adverse Event Report: M I TECH CO LTD HANAROSTENT DUO UNCOVERED 22 DM 12CM (US); STENT, METALLIC, EXPANDABLE, DUODENAL

Model Number DNJF-22-120-230

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/10/2022

Event Type  Injury  

Event Description

The customer reports following an esophagogastroduodenoscopy (egd) with stent removal procedure (for the indication of fractured duodenal stent) using a hanarostent duo uncovered 22 dm 12cm stent, the patient went to the emergency room due to bleeding.A computerized tomography (ct) was completed, and it showed that the stent had fractured and was possibly the cause of the bleeding.Anatomical challenges that could have contributed to the device breaking: difficult angle of anatomical position where stent was deployed.Interventions required as a result of this event include ct, x-ray, admit to hospital, egd, removal of broken stent in stomach.The outcome/result of the follow-up egd performed the next day: removed approximately 3cm of the proximal stent, remainder of stent left in patient.The patient's current condition is reported as: patient left hospital and placed on hospice.

• Brand Name: HANAROSTENT DUO UNCOVERED 22 DM 12CM (US)
• Type of Device: STENT, METALLIC, EXPANDABLE, DUODENAL
• Manufacturer (Section D): M I TECH CO LTD; 174, habuk2-gil; jinwi-myeon; pyeongtaek-si, gyeonggi-do 17706 451-1 73; KS 451-173
• MDR Report Key: 15827935
• MDR Text Key: 303993006
• Report Number: 2429304-2022-00133
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08806367076762
• UDI-Public: 08806367076762
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2022,11/18/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: DNJF-22-120-230
• Device Lot Number: 22041139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG