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

Model Number	M00513750
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Codes	Vomiting (2144); No Code Available (3191)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter's address 1: (b)(6).(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 on august 18, 2020 that an ultraflex esophageal ng distal release covered stent was implanted to treat a malignant stricture at the mid to distal esophagus during a stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was dilated with cre (controlled radial expansion) balloon prior to stent placement.According to the complainant, during the procedure, a 15cm ultraflex esophageal stent was successfully placed stent in stent with another ultraflex esophageal stent.Reportedly, 4 days post stent placement, the patient presented with vomiting.Endoscopy was performed and a pediatric scope was used to access the stricture.It was found out that the 15 cm stent did not fully expand and severe kinking was observed.The stent had wires protruding towards the middle of the stent.Reportedly, the stent remains implanted and the physician was comfortable leaving the stent in placed.The physician placed a ryles tube in the stomach while the patient was under observation before the re-stenting procedure.An 18mm x 15 cm wallflex fully covered stent was placed over the damaged ultraflex stent to complete the procedure.Reportedly, the wallflex stent has effectively opened up against the damaged ultraflex stent and the stricture was managed.The patient's condition at the conclusion of the procedure was reported to be stable.The patient was kept under observation until (b)(6) 2020.A photo of the device implanted in the patient provided by the complainant shows the stent failure to expand and stent wires protruding inwards.Reportedly, in the physician's assessment, there was a relationship between the stent kinking and the patient vomiting.

• 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: 10507007
• Report Number: 3005099803-2020-03523
• Device Sequence Number: 3033685
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 06/27/2021
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0024029662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/09/2020
• 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: 64 YR