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

Model Number	M00513840
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on september 06, 2022, that an ultraflex esophageal ng proximal release covered stent was to be implanted in the esophagus to treat a 6cm malignant stricture during an esophageal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the ultraflex esophageal stent was unable to fully deploy.The ultraflex esophageal stent was partially deployed on the delivery system when it was removed from the patient.The patient's anatomy was then dilated with balloon and another ultraflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
The initial reporter's address is (b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an ultraflex esophageal ng proximal release covered stent was to be implanted in the esophagus to treat a 6cm malignant stricture during an esophageal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the ultraflex esophageal stent was unable to fully deploy.The ultraflex esophageal stent was partially deployed on the delivery system when it was removed from the patient.The patient's anatomy was then dilated with balloon and another ultraflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a15 captures the reportable event of partially deployed ultraflex esophageal proximal release stent.Block h10: an ultraflex esophageal proximal covered stent and delivery system were returned for analysis.The stent was received partially deployed.Visual inspection found the shaft slightly bent.The crocheted suture was inspected, and no damages or knots were noted.Functional inspection revealed that it was possible to deploy the stent by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed as the stent was received partially deployed.It is most likely that the patient's anatomy (tortuous) and the technique used by the physician when deploying the stent contributed to the reported event of stent partially deployed and the observed event of shaft bent.Therefore, review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A product labeling review identified that the device was not used in accordance with the directions for use (dfu) / product label.

• 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: 15486923
• Report Number: 3005099803-2022-05528
• Device Sequence Number: 12795329
• 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): 11/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0026870630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 65 KG