MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HANAROSTENT DUODENUM NCN; M.I. DUODENUM

Model Number	M00565010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Vomiting (2144); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on june 26, 2021 that a wallflex duodenal stent was implanted during a stent placement procedure performed on an unknown date.On an unknown date, during routine follow-up, it was noted that the stent was broken into three pieces and was separated.Another wallflex duodenal stent was implanted and the procedure was completed.There were no patient complications reported as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Blocks b3, b5, d1, d2, d4, d6a (implant date), g1 and h6 (patient code) have been updated based on the additional information received on july 26, 2021.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter city, province and post code: (b)(6).Block h6: medical device problem code a0401 captures the reportable event of stent break.Impact code f2301 captures the additional intervention of a second procedure performed to implant another stent.Block h10: the complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on june 26, 2021 that a wallflex duodenal stent was implanted during a stent placement procedure performed on an unknown date.On an unknown date, during routine follow-up, it was noted that the stent was broken into three pieces and was separated.Another wallflex duodenal stent was implanted and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on july 26, 2021.A hanarostent duodenum stent was implanted on (b)(6) 2021.On (b)(6) 2021, the patient presented with vomiting, a computed tomography (ct) scan was performed and it was noted that the stent was broken.Another hanarostent was implanted stent-in-stent on (b)(6) 2021.

• Brand Name: HANAROSTENT DUODENUM NCN
• Common Device Name: M.I. DUODENUM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12191670
• Report Number: 3005099803-2021-03604
• Device Sequence Number: 14697466
• Product Code: FGE
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention