MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00514250
Medical Device Problem Codes	Use of Device Problem (1670); Component Missing (2306)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and 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 (b)(6) 2019 that an ultraflex esophageal ng proximal release covered stent was implanted in the mid esophagus during a procedure performed on an unknown date to cover an esophageal perforation.According to the complainant, on (b)(6) 2019 about a week after stent implantation, a re-gastroscopy was performed and the cover of the stent was noted to be missing in some parts.The stent was removed with grasping forceps and another ultraflex esophageal stent was placed to seal the perforation.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: according to the complainant, the ultraflex esophageal ng stent was implanted to cover a perforation; however, the ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8510051
• Report Number: 3005099803-2019-01702
• Device Sequence Number: 13933501
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 07/05/2020
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 0022342666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/12/2019
• 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
• Patient Age: 74 YR