MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE STENT

Model Number	3MM X 15 MM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure, balloon ruptured and was removed intact.

• Brand Name: XIENCE ALPINE STENT
• Common Device Name: XIENCE ALPINE STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside dr.; santa clara CA 95054
• MDR Report Key: 6581395
• Report Number: MW5069906
• Device Sequence Number: 746639
• Product Code: NIQ
• UDI-Device Identifier: 08717648199349
• UDI-Public: (01)08717648199349
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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: 01/15/2020
• Device Model Number: 3MM X 15 MM
• Device Catalogue Number: 1125300-15
• Device Lot Number: 7010541
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 62