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

Model Number	26270
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the subclavian vein.During deployment of a 8x66x75 iliac 6f unistep plus reduced profile wallstent, it was noted that the stent folded up on itself and did not deploy properly.The device was removed and the procedure was completed with a non-bsc device.No patient complications were reported and patient status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.The device was received with the stent partially deployed from the device.The middle stent wires were noted to be damaged where they exit the blue outer sheath.The stent was successfully deployed with no issues or resistance experienced.No other issues were noted with the stent.A visual and microscopic examination identified that extreme distal end of the of the blue outer sheath was damaged.No other issues were identified with the delivery system that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the subclavian vein.During deployment of a 8x66x75 iliac 6f unistep plus reduced profile wallstent, it was noted that the stent folded up on itself and did not deploy properly.The device was removed and the procedure was completed with a non-bsc device.No patient complications were reported and patient status was fine.

• 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: 9403035
• Report Number: 2134265-2019-14803
• Device Sequence Number: 14076201
• Product Code: NIO
• UDI-Device Identifier: 08714729345770
• UDI-Public: 08714729345770
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 06/13/2021
• Device Model Number: 26270
• Device Catalogue Number: 26270
• Device Lot Number: 0023953941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1