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

Model Number	M00516710
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(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 july 18, 2018 that a wallflex esophageal fully covered stent was to be used to treat a 5 centimeter malignant stricture in the distal esophagus during a stent placement procedure performed on an unknown date.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, during procedure, the stent was difficult to deploy, force was applied to open the stent and due to the speed/force applied during deployment the stent was incorrectly placed.The stent was removed with rat tooth forceps and a different size stent was used to complete the procedure.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7759106
• Report Number: 3005099803-2018-02497
• Device Sequence Number: 1794313
• Product Code: ESW
• UDI-Device Identifier: 08714729778042
• UDI-Public: 08714729778042
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: 10/17/2019
• Device Model Number: M00516710
• Device Catalogue Number: 1671
• Device Lot Number: 0022004315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/07/2018
• 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 Weight: 91