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

Model Number	M00513740
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/29/2021
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 problem 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 on (b)(6) 2021 that an ultraflex esophageal proximal covered stent was implanted to treat a 6cm malignant esophageal stricture during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.On (b)(6) 2021, post stent placement, the patient presented with discomfort in the stomach.Endoscopy was performed and it was noted that the stent had migrated distally.There was difficulty in removing the stent but it was able to be removed with a snare.The procedure was completed with a different device.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d4 (model number, lot number, catalog number, expiration date, and udi) and h4 have been updated with additional information received on september 13, 2021.Block h6: patient code e2311 captures the reportable event of discomfort.Medical device problem code a150207 captures the reportable event of stent difficult to remove.Medical device problem code a010402 captures the reportable event of stent migration.Impact code f2301 captures reintervention to remove the migrated stent and place another stent.Block h10: an ultraflex esophageal delivery system was received for analysis; the stent, deployment suture, and finger ring were not returned.The delivery system was inspected and no visible damage was noted.No issues with the delivery system was noted.The reported events of stent migration and stent difficult to remove could not be confirmed as these failures occurred during the procedure and could not functionally or visually verified.Additionally, the stent was not returned for analysis and the unit returned did not show evidence of either the reported event or any defect which could have contributed to the event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, stent migration and pain are noted within the ifu as a potential complications post-stent placement with the use of this device.Migration is known and documented in the labeling; therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex esophageal proximal covered stent was implanted to treat a 6cm malignant esophageal stricture during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.On (b)(6) 2021, post stent placement, the patient presented with discomfort in the stomach.Endoscopy was performed and it was noted that the stent had migrated distally.There was difficulty in removing the stent but it was able to be removed with a snare.The procedure was completed with a different device.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 12338002
• Report Number: 3005099803-2021-04213
• Device Sequence Number: 11451489
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 01/19/2023
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0026654498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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