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

Model Number	M00516750
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem 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 august 23, 2021 that a wallflex esophageal fully covered stent was to be implanted to treat an esophageal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2021.During preparation, the white dilation tip of the delivery system detached outside the patient.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex esophageal fully covered stent was to be implanted to treat an esophageal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure perfomed on (b)(6) 2021.During preparation, the white dilation tip of the delivery system detached outside the patient.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of tip detachment of device or device component.Block h10: a wallflex esophageal fully covered stent was received for analysis; the tip was detached from the delivery system and was not returned.The stent was received fully covered and undeployed.Visual examination found that the sheath was kinked.No other issues were noted to the stent.The reported event of tip detachment of device or device component was confirmed; the tip was detached from the delivery system.It is likely that the handling of the device during unpacking, prepping, and testing limited the performance of the device and contributed to the detached tip and kinked sheath.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12466676
• Report Number: 3005099803-2021-04783
• Device Sequence Number: 11665925
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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: 07/19/2022
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0026649148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown