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

Model Number	M00516710
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the suspect 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 relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex esophageal fully covered stent has been implanted to treat a 2-3cm anastomotic stricture post esophagectomy with a malignant extrinsic mass compressing the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent moved to the patient's stomach as seen under fluoroscopy.The stent was attempted to be removed by the stent removal suture, but the physician could not pull the stent past the stricture.Reportedly, the stent was left in the distal esophagus and another wallflex esophageal stent was implanted through the migrated stent to bridge the stricture.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

• 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: 8688483
• Report Number: 3005099803-2019-02965
• Device Sequence Number: 19422921
• Product Code: ESW
• UDI-Device Identifier: 08714729778042
• UDI-Public: 08714729778042
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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: 12/11/2019
• Device Model Number: M00516710
• Device Catalogue Number: 1671
• Device Lot Number: 0022238463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/11/2019
• 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