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

Model Number	M00513850
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664); Material Integrity Problem (2978)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	03/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been disposed 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 (b)(6) 2018 that an ultraflex esophageal ng proximal release covered stent had been implanted six weeks prior to (b)(6) 2018 to treat an iatrogenic perforation in the esophagus caused during a previous endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, six weeks post stent placement on (b)(6) 2018, the patient experienced discomfort which prompted the physician to check the ultraflex esophageal stent.During this check of the stent, a fistula was noted at the proximal end of the stent.On (b)(6) 2018, a stent removal procedure was performed.During the procedure, there was difficulty removing the stent and it became unraveled.The stent cover was also noted to be damaged at one end.The stent was able to be removed and the patient underwent an esophagogram test.Per the physician, the test results were good and revealed no abnormalities.It is unknown how the fistula was treated but per the physician, everything has healed and the patient does not have any of the past symptoms or fistula growth.The physician performed the first dilation on (b)(6) 2018.Note: according to the complainant, the ultraflex esophageal ng proximal release covered stent was placed to treat an iatrogenic perforation caused during an endoscopic retrograde cholangiopancreatography (ercp) procedure.However, per the ultraflex esophageal ng stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7454900
• Report Number: 3005099803-2018-01331
• Device Sequence Number: 1083537
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: Physician
• Device Expiration Date: 08/10/2018
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 19579468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/24/2018
• 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: 24 YR