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

Model Number M00513740

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a15 captures the reportable event of stent partially deployed.

Event Description

It was reported to boston scientific corporation on (b)(6), 2022, that an ultraflex esophageal distal release covered stent was to be implanted in the esophagus to treat a 4cm malignant esophageal stenosis during a stent placement procedure performed on (b)(6), 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent deployment suture broke and the stent could not be fully deployed.The stent was removed from the patient partially deployed.The procedure was not completed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an ultraflex esophageal distal release covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found the finger ring detached from the deployment suture and was not returned.A media inspection was performed of a photo provided by the complainant, and it was observed that the stent was partially deployed.Functional examination was performed by holding the handle hub in the palm of one hand, grasping and retracting the deployment suture with the other hand, and the stent was gradually deployed.No other problems were noted to the stent and delivery system.The reported event of stent partially deployed and stent deployment suture break was confirmed.Taking all available information into consideration, the investigation concluded that the reported events were likely due to factors encountered during the procedure.It may be that lesion characteristics, how the device was handled and/or the technique used by the physician, limited the performance of the device and contributed to the reported events.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.

Event Description

It was reported to boston scientific corporation on november 29, 2022, that an ultraflex esophageal distal release covered stent was to be implanted in the esophagus to treat a 4cm malignant esophageal stenosis during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent deployment suture broke and the stent could not be fully deployed.The stent was removed from the patient partially deployed.The procedure was not completed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 16000197
• MDR Text Key: 307102047
• Report Number: 3005099803-2022-07578
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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: 06/11/2023
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0027473539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 60 KG