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

Model Number	M00516750
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 was to be used during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was successfully deployed.During catheter removal, the delivery system snagged on the stent, and the stent was pulled out from the patient together with the delivery system.The physician used another wallflex esophageal stent to complete the procedure.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex esophageal fully covered stent was to be used during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was successfully deployed.During catheter removal, the delivery system snagged on the stent, and the stent was pulled out from the patient together with the delivery system.The physician used another wallflex esophageal stent to complete the procedure.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
Additional Manufacturer Narrative
Problem code 1528 captures the reportable event of delivery system difficult to remove.A wallflex esophageal delivery system was received for analysis; the stent was not returned.Visual examination of the returned delivery system found a kink in the etube at the proximal end.No other issues with the device were noted.Per analysis, the damage noted to the delivery system was consistent with the application of excessive force during use.According to the complainant, dilation was not performed during the procedure.Therefore, the device may have encountered difficult patient anatomy, resulting in the reported event.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.

• 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: 8001000
• Report Number: 3005099803-2018-60950
• Device Sequence Number: 13503655
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0022585647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1