MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE; CORONARY STENT

Lot Number	5110341
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Stent sheared off of stent catheter while being brought back into guiding catheter.

• Brand Name: XIENCE ALPINE
• Common Device Name: CORONARY STENT
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA 95054
• MDR Report Key: 5553779
• Report Number: MW5061522
• Device Sequence Number: 362208
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: (01)08717648199219
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/04/2016

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 Lot Number: 5110341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 112