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

Model Number	26270
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent separated from the delivery system.The stent was not returned for analysis.A visual and microscopic examination identified no damage or issues with the stent cups or the stent holder.The stent impression was evident on the stent holder.A visual and tactile examination found the outer to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual examination of the inner shaft found it to be completely detached from the metal shaft at its bond.This type of damage is consistent with excessive tensile force being applied to the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2020.A 10x69x75/ iliac 6f unistep plus wallstent rp endoprosthesis was used with no known issues reported.However, returned device analysis revealed stent detachment and shaft break.

• 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: 9865591
• Report Number: 2134265-2020-03695
• Device Sequence Number: 526323
• Product Code: NIO
• UDI-Device Identifier: 08714729345923
• UDI-Public: 08714729345923
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P940019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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: 02/23/2020
• Device Model Number: 26270
• Device Catalogue Number: 26270
• Device Lot Number: 0021784276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1