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

Model Number	M00516700
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device code relates to problem code for the reported event of stent migration.According to the complainant, the suspect device was contaminated 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 (b)(6) 2018 that a wallflex esophageal fully covered stent has been implanted to treat a malignant stricture in the esophagus during a stenting procedure performed on (b)(6) 2018.According to the complainant, post stent placement, on (b)(6) 2018, the patient underwent a scheduled gastroscopy per protocol to check for stent placement.The image revealed the stent had migrated.The stent was removed with forceps and a second stent was implanted in the same location.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion was reported to be stable.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7627546
• Report Number: 3005099803-2018-01923
• Device Sequence Number: 2067301
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: 08714729778035
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K091510
• 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): 05/30/2018

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: 10/23/2018
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Device Lot Number: 0020558672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/21/2018
• 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: 76 YR
• Patient Weight: 106