MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX? ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00513740
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Material Deformation (2976); Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582); Biliary Leak (4820)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block 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 lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a04 captures the reportable event of stent cover damaged.Imdrf device code a010402 captures the reportable event of stent cover migration.Imdrf impact code f2202 captures the reportable event of endoscopic procedure to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was used during a stent placement procedure performed on an unknown date.Post stent placement, it was observed that the cover of the ultraflex esophageal stent was damaged and had disappeared due to exposure to acid.It was also noted that the stent cover had migrated.The stent was removed, and another device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5, h6 (patient code) have been corrected following a medical review that requested to include ar code of unretrieved device fragments (udf).Block 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 lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a04 captures the reportable event of stent cover damaged.Imdrf device code a010402 captures the reportable event of stent cover migration.Imdrf impact code f2202 captures the reportable event of endoscopic procedure to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was used during a stent placement procedure performed on an unknown date.Post stent placement, it was observed that the cover of the ultraflex esophageal stent was damaged and had disappeared due to exposure to acid.It was also noted that the stent cover had migrated.The stent was removed, and another device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) have been updated based on the additional information received on may 12, 2025.Block 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 lot number.Therefore, the manufacture and expiration dates are unknown.Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a04 captures the reportable event of stent cover damaged.Imdrf device code a010402 captures the reportable event of stent cover migration.Imdrf impact code f2202 captures the reportable event of endoscopic procedure to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was used during a stent placement procedure performed on an unknown date.Post stent placement, it was observed that the cover of the ultraflex esophageal stent was damaged and had disappeared due to exposure to acid.It was also noted that the stent cover had migrated.The stent was removed, and another device was used to complete the procedure.There were no patient complications reported as a result of this event.Additional information received on may 12, 2025.It was reported that the stent was placed due to boerhaave syndrome in most cases, and some post operative esophageal leakages.Note: it was reported that the ultraflex esophageal stent was implanted to treat boerhaave syndrome, and some post operative esophageal leakages.However, per the ultraflex esophageal ng stent system directions for use (dfu), the ultraflex esophageal ng stent system is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal covered stent system is also indicated for occlusion of concurrent esophageal fistula.
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes and patient code) have been updated based on the additional information received on june 05, 2025.Block 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 lot number.Therefore, the manufacture and expiration dates are unknown.Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a04 captures the reportable event of stent cover damaged.Imdrf device code a010402 captures the reportable event of stent cover migration.Imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf patient code e1108 captures the reportable event of biliary leak.Imdrf impact code f2202 captures the reportable event of endoscopic procedure to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was used during a stent placement procedure performed on an unknown date.Post stent placement, it was observed that the cover of the ultraflex esophageal stent was damaged and had disappeared due to exposure to acid.It was also noted that the stent cover had migrated.The stent was removed, and another device was used to complete the procedure.There were no patient complications reported as a result of this event.***additional information received on may 12, 2025*** it was reported that the stent was placed due to boerhaave syndrome in most cases, and some post operative esophageal leakages.Note: it was reported that the ultraflex esophageal stent was implanted to treat boerhaave syndrome, and some post operative esophageal leakages.However, per the ultraflex esophageal ng stent system directions for use (dfu), the ultraflex esophageal ng stent system is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal covered stent system is also indicated for occlusion of concurrent esophageal fistula.***additional information received on june 05, 2025*** it was reported that despite correct stent position, there were signs of recurrent leakage (with bile/gastric content production out of external drain).Note: a review of the photos of the complaint device showed that the stent was broken and deformed.
Additional Manufacturer Narrative
Block h6 (patient code and impact code) was corrected following a review received on august 20, 2025, which confirmed that the stents in scope for the ultraflex esophageal stents sef are esophageal stents, not biliary.Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Imdrf device code a04 captures the reportable event of stent cover damaged.Imdrf device code a010402 captures the reportable event of stent cover migration.Imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf impact code f2202 captures the reportable event of endoscopic procedure to remove the stent.Imdrf impact code f0101 captures the reportable event of there were signs of recurrent leakage (with bile/gastric content production out of external drain).
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was used during a stent placement procedure performed on an unknown date.Post stent placement, it was observed that the cover of the ultraflex esophageal stent was damaged and had disappeared due to exposure to acid.It was also noted that the stent cover had migrated.The stent was removed, and another device was used to complete the procedure.There were no patient complications reported as a result of this event.***additional information received on may 12, 2025*** it was reported that the stent was placed due to boerhaave syndrome in most cases, and some post operative esophageal leakages.Note: it was reported that the ultraflex esophageal stent was implanted to treat boerhaave syndrome, and some post operative esophageal leakages.However, per the ultraflex esophageal ng stent system directions for use (dfu), the ultraflex esophageal ng stent system is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal covered stent system is also indicated for occlusion of concurrent esophageal fistula.***additional information received on june 05, 2025*** it was reported that despite correct stent position, there were signs of recurrent leakage (with bile/gastric content production out of external drain).Note: a review of the photos of the complaint device showed that the stent was broken and deformed.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21922242
• Report Number: 3005099803-2025-01903
• Device Sequence Number: 9073659
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: (01)08714729716167
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K130004
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/03/2025

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: M00513740
• Device Catalogue Number: M00513740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 05/12/2025; 06/05/2025; 08/20/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/19/2025; 06/06/2025; 07/01/2025; 09/03/2025
• 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