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

Model Number	M00513860
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng stent was implanted in the esophagus during a stenting procedure performed on (b)(6) 2020.According to the complainant, post stent placement, on (b)(6) 2020 the stent was found to be slightly broken in the middle.Another ultraflex esophageal ng stent was placed stent-in-stent to cover the broken portion of the stent to resolve the issue.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.
Additional Manufacturer Narrative
Block b5 was updated with additional information received on (b)(6), 2020.Block h6: patient code 3191 captures the additional intervention to place an additional ultraflex stent during a second procedure.Problem code 1069 captures the reportable event of stent break.Block h10: the complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng stent was implanted in the esophagus during a stenting procedure performed on (b)(6), 2020.According to the complainant, post stent placement, on (b)(6), 2020 the stent was found to be slightly broken in the middle.Another ultraflex esophageal ng stent was placed stent-in-stent to cover the broken portion of the stent to resolve the issue.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.Additional information received on (b)(6), 2020 reportedly, the patient did not experience symptoms or adverse events related to the stent break causing the patient to be hospitalized.The patient was already hospitalized when the physician discovered a leak in the stent.

• 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: 9898489
• Report Number: 3005099803-2020-01359
• Device Sequence Number: 16703898
• Product Code: ESW
• UDI-Device Identifier: 08714729716082
• UDI-Public: 08714729716082
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: 08/20/2021
• Device Model Number: M00513860
• Device Catalogue Number: 1386
• Device Lot Number: 0024301026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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: 72 YR