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

Model Number	M00516900
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dysphagia/ Odynophagia (1815)
Date of Event	02/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on february 13, 2018 that a wallflex esophageal partially covered stent was implanted to treat a malignant stricture of the distal esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the patient presented with abdominal pain and increased dysphagia.An esophagogastroduodenoscopy (egd) was performed and showed that the stent had migrated distally in the esophagus.In the physician's assessment, the relationship between the stent placement and the abdominal pain is unknown, but the stent contributed to the patient's dysphagia.The stent was removed from the patient using forceps on (b)(6) 2018.Reportedly, the patient had radiation treatment and chose not to have a new stent implanted.There were no patient complications reported after the stent was explanted.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7321529
• Report Number: 3005099803-2018-00670
• Device Sequence Number: 1605091
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073266
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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: 01/02/2020
• Device Model Number: M00516900
• Device Lot Number: 21556722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/07/2018
• 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
• Patient Age: 77 YR