MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	26265
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent difficulty to reconstrain was encountered.The 50% stenosed target lesion was located in a mildly tortuous vessel in the bile duct.A 8x40x75/ 6f wallstent rp endoprosthesis stent was used to continue the procedure.The physician positioned and adjusted the stent before it was released to the non-retrievable marker; however, it was found that the stent needed to be constrained and adjusted again.When the stent was constrained, the resistance was so great that it could not be constrained at all, then the stent was released.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9251001
• Report Number: 2134265-2019-13088
• Device Sequence Number: 2172410
• Product Code: FGE
• UDI-Device Identifier: 08714729406372
• UDI-Public: 08714729406372
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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: 03/24/2021
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0023534700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/29/2019
• 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: Other
• Patient Age: 54 YR
• Patient Weight: 70