MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number	M00516740
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device code relates to problem code for the reported event of stent positioning/ placement problem.The device has been received for analysis; however 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 medwatch 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 to treat a malignant stenosis in the cardia of the esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, when the stent was viewed endoscopically to check for placement, the stent was noted to have moved towards the stomach due to peristalsis.The stent was removed with forceps and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
A deployed wallflex esophageal fully covered stent and delivery system were returned for analysis.Visual examination of the returned device found the proximal handle was bent.The stent was measured to be within specifications.There were no issues noted with the stent and no other issues were noted with the device.The damage noted with the device was consistent with the application of excessive force during usage and deployment.Taking all available information into consideration, the investigation concluded that the reported failure was likely due to anatomical or procedural factors encountered during the procedure, such as characteristics of the lesion, which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.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.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
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 to treat a malignant stenosis in the cardia of the esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, when the stent was viewed endoscopically to check for placement, the stent was noted to have moved towards the stomach due to peristalsis.The stent was removed with forceps and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7304649
• Report Number: 3005099803-2018-00587
• Device Sequence Number: 1741442
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 02/08/2018

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 Expiration Date: 09/20/2018
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Device Lot Number: 20432714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 05/04/2018
• 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: 63 YR