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

Device Problem Obstruction of Flow (2423)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the stent remains implanted; therefore, a product analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of two wallflex esophageal stents used in the same patient.Refer to manufacturer report # 3005099803-2021-07957 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex esophageal stent was implanted to treat a malignant esophageal stricture during an endoscopy procedure performed on an unknown date.Reportedly, the patient's anatomy was not tight prior to stent placement.A few months after the first wallflex esophageal stent (the subject of this report) was implanted, the patient presented with dysphagia.Endoscopy was performed and ingrowth was noted.A stent-in-stent procedure was done using another wallflex esophageal stent (the subject of mfr.# 3005099803-2021-07957) to complete the procedure.Three weeks after the stent-in-stent procedure, the patient presented with dysphagia and ingrowth was again noted.Reportedly, ablation and a stent-in-stent procedure was done to complete the procedure.

Event Description

Note: this report pertains to one of two wallflex esophageal stents used in the same patient.Refer to manufacturer report 3005099803-2021-07957 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex esophageal stent was implanted to treat a malignant esophageal stricture during an endoscopy procedure performed on an unknown date.Reportedly, the patient's anatomy was not tight prior to stent placement.A few months after the first wallflex esophageal stent (the subject of this report) was implanted, the patient presented with dysphagia.Endoscopy was performed and ingrowth was noted.A stent-in-stent procedure was done using another wallflex esophageal stent (the subject of mfr.# 3005099803-2021-07957) to complete the procedure.Three weeks after the stent in stent procedure, the patient presented with dysphagia and ingrowth was again noted.Reportedly, ablation and a stent-in-stent procedure was done to complete the procedure.Additional information received on december 21, 2021.It was reported that both stents were non-removable, partially covered wallflex esophageal stents.

Manufacturer Narrative

Blocks b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: medical device problem code a1409 captures the reportable event of stent ingrowth.Impact code f2301 captures the additional intervention of another stent placement.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; therefore, a product 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 based on additional information received on december 21, 2021.

• Brand Name: WALLFLEX ESOPHAGEAL
• Type of Device: 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: 13094219
• MDR Text Key: 282820248
• Report Number: 3005099803-2021-07958
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention