MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00513840
Medical Device Problem Codes	Difficult to Remove (1528); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device 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 (b)(6) 2017 that an ultraflex¿ esophageal proximal release covered stent was implanted in the esophagus to treat a 3 cm neoplastic stenosis in the upper esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.Reportedly, the patient was sedated and vital parameters were continuously monitored.According to the complainant, 19 to 23 cm from the oral fissure, a 3 cm neoplastic stenosis was noted in the upper esophagus.The physician used a pediatric gastro scope to pass through the stricture.At the cardia level, 39 to 43 cm from the oral fissure, another 5 cm neoplastic stricture was noted.A guidewire was inserted up to the duodenum and it was noted that the stent had difficulty crossing the stenosis.The stricture was dilated for about 10 mm and the stent deployed below the upper esophageal sphincter, 20 to 21 cm from the oral fissure.After deployment, it was noted that the proximal end of the stent did not fully expand.A 15mm dilatation was performed with good balloon inflation.On (b)(6) 2017, a scheduled check -up was done for stent placement to treat the cardia stenosis.It was noted that the stent implanted in the upper esophagus still had not expanded.The physician removed the stent with difficulty using a dual-channel instrument and an overtube.The physician used a different expandable stent to treat the esophageal stenosis and another ultraflex esophageal stent to treat the cardia stenosis.( the treatment for cardia stenosis is captured by manufacturer report# 3005099803-2017-01155).There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion of the procedure was reported to be good.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6503212
• Report Number: 3005099803-2017-01132
• Device Sequence Number: 734355
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: (01)08714729716099(17)20180504(10)0019218833
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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: 05/04/2018
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0019218833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/19/2017
• 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