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

Model Number 26270

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  malfunction  

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 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
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9865591
• MDR Text Key: 184472014
• Report Number: 2134265-2020-03695
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729345923
• UDI-Public: 08714729345923
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1