MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; STENT, CORONARY

Model Number	26270
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 10x69x135 wallstent rp endoprosthesis was advanced for treatment.However, when the device was taken out of the patient's body, the stent edge was slightly flattened.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9305763
• Report Number: 2134265-2019-13612
• Device Sequence Number: 2362961
• Product Code: NIO
• UDI-Device Identifier: 08714729345930
• UDI-Public: 08714729345930
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: 26270
• Device Catalogue Number: 26270
• Device Lot Number: 0021691568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1