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

Model Number	M00516750
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on september 29, 2018 that a wallflex esophageal fully covered stent was to be used to treat a malignant stricture due to esophageal cancer during an endoscopic retrograde cholangiopancreatography (ercp) with esophageal stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tight and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent fell into the stomach right after it was deployed in the esophagus.The stent was removed with forceps and another wallflex esophageal stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
H6: problem code 3009 captures the reportable event of stent positioning/ placement problem.H10: a deployed wallflex esophageal fully covered stent and delivery system were returned for analysis.The stent was received fully expanded.Visual examination of the returned device identified no issues with the stent and delivery system.The stent was measured to be within specifications.The investigation concluded that procedural factors such as the handling of the device and normal procedural difficulties encountered during the procedure could have affected the device performance contributing to 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.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 03:28 pm ct.The report number is being corrected from: 3005099803-2018-61982 to: 3005099803-2018-60991.
Event or Problem Description
It was reported to boston scientific corporation on september 29, 2018 that a wallflex esophageal fully covered stent was to be used to treat a malignant stricture due to esophageal cancer during an endoscopic retrograde cholangiopancreatography (ercp) with esophageal stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tight and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent fell into the stomach right after it was deployed in the esophagus.The stent was removed with forceps and another wallflex esophageal stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• 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: 8004990
• Report Number: 3005099803-2018-60991
• Device Sequence Number: 427563
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

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: 07/19/2018
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0020176288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 09/29/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 01/25/2019
• 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