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

Model Number	M00514200
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng stent was to be implanted to treat a malignant esophagus stenosis during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, after the stent was placed in the correct position and the suture was removed the physician saw that the stent was not fully expanded and the stent was torqued.The ultraflex esophageal ng stent was removed from the patient and the procedure was completed with a non-boston scientific cook stent.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, good, and fine.
Additional Manufacturer Narrative
Block h6: problem code 3270 captures the reportable event of stent failure to expand.Problem code 2976 captures the reportable event of stent material deformation.Evaluation code 114 captures the reportable event of stent cover damaged.Block h10: an ultraflex esopahgeal ng distal release covered stent and delivery system were returned for analysis.A media inspection of photos provided by the complainant noted that the stent was not fully expanded and deformed.However, a visual examination of the returned device found the stent was received fully deployed and expanded.A kink at the shaft approximately at 20cm and 64cm from the tip of the delivery system was also noted.The stent cover was inspected and was found damaged.The stent was measured to be within specification.No other issues with the stent and delivery system were noted.The investigation concluded that based on the event details, media and device analysis, the reported event and the observed failures may likely due to some factors encountered during the procedure such as how the device was handled or manipulated, the techniques used by the user, and the anatomy of the patient, which limited the performance of the device.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng stent was to be implanted to treat a malignant esophagus stenosis during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, after the stent was placed in the correct position and the suture was removed the physician saw that the stent was not fully expanded and the stent was torqued.The ultraflex esophageal ng stent was removed from the patient and the procedure was completed with a non-boston scientific cook stent.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, good, and fine.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10053611
• Report Number: 3005099803-2020-01909
• Device Sequence Number: 2782881
• Product Code: ESW
• UDI-Device Identifier: 08714729121190
• UDI-Public: 08714729121190
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 04/04/2021
• Device Model Number: M00514200
• Device Catalogue Number: 1420
• Device Lot Number: 0023598331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR