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

Model Number	M00516750
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); No Code Available (3191)
Date of Event	04/22/2019
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.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch 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 was implanted to treat a malignant stricture during a stent placement procedure performed on an unknown date.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2019 five days post stent placement, the patient presented with dysphagia.An esophagogastroduodenoscopy (egd) procedure was performed and noticed that the stent had migrated into the stomach.The stent was removed from the patient by grabbing the stent suture with a raptor forceps.Reportedly, the stent suture broke.The procedure was completed by implanting a different 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.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the manufacture and expiration dates are unknown.Block h6: problem code 4003 captures the reportable event of stent migration.Problem code 1069 captures the reportable event of stent suture broke.Patient code 3191 captures the additional intervention to remove the stent.Block h10: a wallflex esophageal fully covered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was deployed and expanded.The stent suture was detached and not returned.The stent was measured to be within specification.No other issues with the stent were noted.The damage noted to the returned device was likely due to excessive force applied during attempted stent removal.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Stent migration and recurrent dysphagia were noted within the dfu as a potential adverse effects associated with the use of this device.Therefore, the most probable root cause is known inherent risk of device.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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex esophageal fully covered stent was implanted to treat a malignant stricture during a stent placement procedure performed on an unknown date.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2019 five days post stent placement, the patient presented with dysphagia.An esophagogastroduodenoscopy (egd) procedure was performed and noticed that the stent had migrated into the stomach.The stent was removed from the patient by grabbing the stent suture with a raptor forceps.Reportedly, the stent suture broke.The procedure was completed by implanting a different 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: 8637663
• Report Number: 3005099803-2019-02642
• Device Sequence Number: 16613221
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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 Model Number: M00516750
• Device Catalogue Number: 1675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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