MAUDE Adverse Event Report: ABBOT VASCULAR MULTI-LINK VISION; STENT

Model Number REF 1010145-23

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2014

Event Type  malfunction  

Event Description

Pt was having a lhc/ptci of rca and the stent didn't cross.No harm to pt.

• Brand Name: MULTI-LINK VISION
• Type of Device: STENT
• Manufacturer (Section D): ABBOT VASCULAR; santa clara CA 95054
• MDR Report Key: 4398656
• MDR Text Key: 5121746
• Report Number: MW5040052
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: REF 1010145-23
• Device Lot Number: 2120641
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIVALIRUDIN 250 MG +DEXTROSE 5% IN WATER 50ML; INFUSING
• Patient Age: 60 YR
• Patient Weight: 89