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

Model Number M00516910

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

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 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 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.

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
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12127309
• MDR Text Key: 260233360
• Report Number: 3005099803-2021-03231
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• Combination Product (y/n): N
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1