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

Model Number	M00513840
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has been received for analysis; however, the evaluation has not been completed.Therefore, the cause of the reported serious injury has not been determined.Upon completion of the failure 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) 2018, that an ultraflex esophageal ng proximal release covered stent was to be used to treat a malignant stricture in the esophagus 12 cm from the row of teeth during a gastroscopy with stent placement procedure performed on (b)(6) 2018.Reportedly, the anatomy of the patient was very tight.According to the complainant, during the procedure, the physician was able to deploy the stent.However, the stent failed to expand at the flare/tulip.The physician tried to dilate the stent using a dilation balloon, however, the stent still failed to expand.The physician removed the stent using forceps and the procedure was not completed due to this event.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 stable.
Additional Manufacturer Narrative
An ultraflex esophageal ng proximal release covered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found broken green retention suture at the proximal end of the stent.The stent was measured to be within specifications.No other issues noted with the device.The damage noted with the device was consistent with the application of excessive force applied during stent removal.The investigation concluded that the observed failure and the reported event were likely due to anatomical or procedural factors which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018, that an ultraflex esophageal ng proximal release covered stent was to be used to treat a malignant stricture in the esophagus 12 cm from the row of teeth during a gastroscopy with stent placement procedure performed on (b)(6) 2018.Reportedly, the anatomy of the patient was very tight.According to the complainant, during the procedure, the physician was able to deploy the stent.However, the stent failed to expand at the flare/tulip.The physician tried to dilate the stent using a dilation balloon, however, the stent still failed to expand.The physician removed the stent using forceps and the procedure was not completed due to this event.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 stable.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7237503
• Report Number: 3005099803-2018-00154
• Device Sequence Number: 1213649
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: Health Professional
• Device Expiration Date: 10/11/2019
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 21242724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 03/15/2018
• 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