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

Model Number	M00516940
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal partially covered stent was implanted in the esophagus during a procedure performed on an unknown date.On (b)(6) 2022, 4 weeks post stent implant, the stent was attempted to be removed.During the procedure, while attempting to remove the stent with grasping forceps, the stent retrieval suture broke and the stent was unable to be removed.The procedure was not completed due to this event and the patient was scheduled for another stent removal.There were no patient complications reported as a result of this event.Note: it was reported that the stent was attempted to be removed 4 weeks post implant.Per wallflex esophageal partially covered stent system instructions for use (ifu): "warning: stent is considered to be a permanent device.Once stent placement is permanently achieved, stent removal or repositioning is not recommended".The user did not follow the warning noted in the ifu.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 14491481
• Report Number: 3005099803-2022-02765
• Device Sequence Number: 20292773
• Product Code: ESW
• UDI-Device Identifier: 08714729765288
• UDI-Public: 08714729765288
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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: M00516940
• Device Catalogue Number: 1694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown