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

Model Number	M00516710
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported the device was not used past its expiry date.The physician who performed the attempted stent removal procedure is dr.(b)(6) of (b)(6) medical ctr (b)(6).(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further information is identified, a supplement medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on september 27, 2018 that a wallflex esophageal fully covered stent was implanted to treat an 8 cm malignant stricture in the distal esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2018.Reportedly, the stent was implanted at (b)(6) medical center (b)(6).The patient's anatomy was not tortuous and was not dilated prior to stent placement.It was reported that the patient has undergone radiation /chemotherapy during the time following stent placement.According to the complainant, on (b)(6) 2018, x-ray was performed by another facility and found the stent had migrated into the stomach.Reportedly, on the same day, the patient was brought back to (b)(6) medical center (b)(6) and removal of the stent was attempted but without success.As per the physician, stent migration was not due to stricture resolution.Reportedly, the physician was comfortable leaving the stent in place and has no plan to remove the stent.There were no patient complications reported as a result of this event. the patient's condition following the procedure was reported to be fine.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7981720
• Report Number: 3005099803-2018-60934
• Device Sequence Number: 11201493
• Product Code: ESW
• UDI-Device Identifier: 08714729778042
• UDI-Public: 08714729778042
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

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 Model Number: M00516710
• Device Catalogue Number: 1671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/18/2018
• 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: 62 YR