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

Model Number M00513730

Device Problems Break (1069); Unraveled Material (1664); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Imdrf device code a040508 captures the reportable product investigation result of stent unraveled.Imdrf device code a0401 captures the reportable product investigation result of stent detached/separated.An ultraflex esophageal stent and delivery system were returned for analysis.Media inspection was performed based on the photo provided by the complainant and showed the shaft was bent in two sections and the stent was fully deployed.Visual examination of the returned device found the stent was fully deployed and expanded.The stent wires were unraveled and broken, and the shaft was bent.No other issues were noted to the stent and delivery system.Product analysis did not confirm the reported event of stent partially deployed; the stent was returned fully deployed and expanded.However, the reported device malfunction of shaft bent was confirmed.The damages noted were most likely due to procedural factors encountered during the procedure, such as lesion characteristics, handling of the device, the techniques used by the user, limited the performance of the device and could have caused kinking of the delivery shaft.Additionally, handling and manipulation of the stent during removal could have resulted to stent wire broke and unraveled.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a 6cm malignant esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2022.The patient anatomy was not tortuous and was dilated prior to stent placement.During the procedure, after opening the package, the black stent deployment suture unraveled, and the stent was deployed partially.The procedure was completed with a wallflex esophageal stent.There were no patient complications reported.A photo of the complaint device was provided by the complainant and showed the shaft was bent and the stent was fully deployed and expanded.It is possible that the physician fully deployed the stent outside the patient.Note: this complaint has been deemed an mdr reportable event based on the product investigation which revealed that the stent wire break and unravel.

Manufacturer Narrative

Blocks b5 and h6 have been updated with the additional information received on january 30, 2024.Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a040508 captures the reportable product investigation result of stent unraveled.Imdrf device code a0401 captures the reportable product investigation result of stent detached/separated.Block h10: an ultraflex esophageal stent and delivery system were returned for analysis.Media inspection was performed based on the photo provided by the complainant and showed the shaft was bent in two sections and the stent was fully deployed.Visual examination of the returned device found the stent was fully deployed and expanded.The stent wires were unraveled and broken, and the shaft was bent.No other damages were noted to the stent and delivery system.Product analysis did not confirm the reported event of stent partially deployed; the stent was returned fully deployed and expanded.However, the reported device malfunction of shaft bent was confirmed.The damages noted were most likely due to procedural factors encountered during the procedure, such as lesion characteristics, handling of the device, the techniques used by the user, limited the performance of the device and could have caused kinking of the delivery shaft.Additionally, handling and manipulation of the stent during removal could have resulted to stent wire broke and unraveled.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a 6cm malignant esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2022.The patient anatomy was not tortuous and was dilated prior to stent placement.During the procedure, after opening the package, the black stent deployment suture unraveled, and the stent was deployed partially.The procedure was completed with a wallflex esophageal stent.There were no patient complications reported.A photo of the complaint device was provided by the complainant and showed the shaft was bent and the stent was fully deployed and expanded.It is possible that the physician fully deployed the stent outside the patient.Note: this complaint has been deemed an mdr reportable event based on the product investigation which revealed that the stent wire break and unravel.Additional information received on january 30, 2024.It was reported that the procedure on (b)(6) 2022, was not completed, and the wallflex esophageal stent was implanted during a second procedure performed on (b)(6) 2022.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• 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: 16709044
• MDR Text Key: 312976277
• Report Number: 3005099803-2023-01814
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0028049366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 60 KG