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

Model Number	M00513840
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: initial reporter's address is no.(b)(6); reported here as the address exceeded character limit for designated field.Block h6: imdrf device code a04 captures the reportable event of tip bent.Imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal proximal covered stent was used in the esophagus to treat a 6cm benign stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was moderately tortuous and was not dilated prior to stent placement procedure.During the procedure, upon unpacking the device, it was noted that the bulbous tip of the stent was bent.Subsequently, after entering inside the patient, the wire wrapping the stent cut the tumor tissue.The stent was withdrawn partially covered by the deployment suture on the delivery system and was removed using forceps.There was no intervention or treatment done to address the tissue damage.The procedure was completed with another ultraflex esophageal stent.The patient's condition following procedure was reported to be stable.Note: it was reported that the ultraflex esophageal stent was used to treat a 6cm benign stenosis.However, per the ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.The device is not indicated for the treatment of a benign stenosis.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal proximal covered stent was used in the esophagus to treat a 6cm benign stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was moderately tortuous and was not dilated prior to stent placement procedure.During the procedure, upon unpacking the device, it was noted that the bulbous tip of the stent was bent.Subsequently, after entering inside the patient, the wire wrapping the stent cut the tumor tissue.The stent was withdrawn partially covered by the deployment suture on the delivery system and was removed using forceps.There was no intervention or treatment done to address the tissue damage.The procedure was completed with another ultraflex esophageal stent.The patient's condition following procedure was reported to be stable.Note: it was reported that the ultraflex esophageal stent was used to treat a 6cm benign stenosis.However, per the ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.The device is not indicated for the treatment of a benign stenosis.
Additional Manufacturer Narrative
Block e1: initial reporter's address is (b)(6); reported here as the address exceeded character limit for designated field.Block h6: imdrf device code a04 captures the reportable event of tip bent.Imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an ultraflex esophageal proximal covered delivery system was received for analysis; the stent was not returned.Visual inspection found that the tip was bent.No other problems were noted with the delivery system.The reported event of tip damaged/defective was confirmed.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted to the reported event of tip damaged/defective.However, the reported event of stent partially deployed was not confirmed because the stent was not returned.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the stent was used to treat a 6cm benign stenosis.However, the ifu states, "the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.".

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20353974
• Report Number: 3005099803-2024-04903
• Device Sequence Number: 6546189
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091816
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Expiration Date: 11/07/2024
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0030497636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 51 KG