MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00514250
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code (no code available) has been used to address the reported event of patient undergoing a surgical procedure to treat the open fistula.Device code relates to problem code for the reported event of stent cover damage.The device has not been received for analysis; 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
This manufacturer report pertains to one of two devices used in the same patient.Refer to manufacturer report # 3005099803-2018-01061 and 3005099803-2018-01062 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2018 that two ultraflex esophageal ng proximal release covered stents had been implanted to treat a malignant stricture concurrent with an esophageal fistula during two stent placement procedures.According to the complainant, on (b)(6) 2018, the first ultraflex stent (the subject of report# 3005099803-2018-01061) was successfully deployed inside the patient.However, on (b)(6) 2018, the patient presented symptoms associated with esophageal fistula which prompted the physician to check the stent.It was noted that the stent cover was damaged and the fistula remained open.The physician removed the first stent with forceps and a second ultraflex esophageal ng proximal release covered stent (the subject of this report) was implanted on the same target site.Reportedly, on (b)(6) 2018, the patient was not well due to the same reason; the stent cover was damaged and the fistula was still open.On the same day, the second stent was removed with forceps.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be okay.However, the physician reported that the patient was to be sent for a surgery the day after the second stent removal on (b)(6) 2018 to treat the open fistula.The name of the surgery was not reported.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7390558
• Report Number: 3005099803-2018-01062
• Device Sequence Number: 679947
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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 Expiration Date: 01/12/2020
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 0021602975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/02/2018
• 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