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

Model Number	M00516720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 october 24, 2017 that a wallflex esophageal fully covered stent was to be used to treat a malignant esophageal stenosis during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician placed the patient under complete sedation before introducing the stent delivery system.As the stent delivery system was being inserted into the esophagus, the patient coughed.The physician removed the delivery system from the patient but the contrast media was aspirated into the lungs.Reportedly, the physician took ¿emergency measures¿ to resolve the aspiration and plans to implant another stent.The patient¿s condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
A fully constrained wallflex esophageal fully covered stent and delivery system was received for analysis.The green braided polyester suture was inspected and no issues were observed.Visual examination of the returned device found the stent to be within specifications.Functional evaluation found it was possible to deploy the stent using the delivery system as received.No issues were noted to the stent and no other issues were noted to the device during the product analysis.A labeling review was performed, and from the information available this device was used per the directions for use (dfu)/product label.Additionally, aspiration is indicated within the dfu as a potential adverse event.Taking all available information into consideration, the investigation concluded that the event is due to a known physiological effect of the procedure noted within the directions for use and/ or device labeling.Therefore, the most probable root cause assigned for this event is anticipated procedural complication.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) 2017 that a wallflex esophageal fully covered stent was to be used to treat a malignant esophageal stenosis during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician placed the patient under complete sedation before introducing the stent delivery system.As the stent delivery system was being inserted into the esophagus, the patient coughed.The physician removed the delivery system from the patient but the contrast media was aspirated into the lungs.Reportedly, the physician took ¿emergency measures¿ to resolve the aspiration and plans to implant another stent.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: 7034500
• Report Number: 3005099803-2017-03435
• Device Sequence Number: 16168684
• Product Code: ESW
• UDI-Device Identifier: 08714729778059
• UDI-Public: 08714729778059
• 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): 10/24/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2018
• Device Model Number: M00516720
• Device Catalogue Number: 1672
• Device Lot Number: 20573816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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: 89 YR
• Patient Weight: 75