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

Model Number	M00516910
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a failure 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) 2021 that a wallflex esophageal partially covered stent was implanted for extrinsic compression of the esophagus during an esophageal stenting procedure performed on (b)(6) 2021.During the procedure, the physician used a partially covered stent; however, after deployment, it was noted that the proximal part of the stent was covered.The stent remains implanted.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 good.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex esophageal partially covered stent was implanted for extrinsic compression of the esophagus during an esophageal stenting procedure performed on (b)(6), 2021.During the procedure, the physician used a partially covered stent; however, after deployment, it was noted that the proximal part of the stent was covered.The stent remains implanted.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 good.**review of record on (b)(6) 2021** during the procedure, the stent was incorrectly labeled.The original stent remains implanted.Note: it was reported that the label indicated the stent was a partially covered stent which is supposed to have an uncovered proximal end; however, the proximal end of the stent was covered.
Additional Manufacturer Narrative
Block h6: medical device problem code a2101 captures the reportable event of labeling issue.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: block b5 has been corrected to make the event description more robust after review of the record on (b)(6), 2021.

• 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: 12127309
• Report Number: 3005099803-2021-03231
• Device Sequence Number: 17228809
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 10/14/2022
• Device Model Number: M00516910
• Device Catalogue Number: 1691
• Device Lot Number: 0026183174
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1