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

Model Number	M00513860
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex esophageal ng proximal release covered stent was implanted to treat an esophageal anastomotic dehiscence during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was not dilated prior to stent placement and the patient underwent chemotherapy and radiation prior to the initial surgery.According to the complainant, on (b)(6) 2017, 8 days post stent placement, bile was coming out through the patient¿s intubation tube, which prompted the physician to check the stent.The physician performed an esophagogastroduodenoscopy (egd) procedure and found that a part of the stent cover had disappeared.According to the physician, the stent had failed to resolve the dehiscence and a 4 cm broncho-esophagic fistula was noted.The patient was sent to urgent surgery and the physician performed cervical esophagectomy, gastrostomy, and muscle plasty over the broncho-esophagic fistulae.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7119103
• Report Number: 3005099803-2017-03817
• Device Sequence Number: 11136754
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: 08714729716082
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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: 02/20/2019
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 20309616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/14/2017
• 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