MAUDE Adverse Event Report: ABBOTT VASCULAR WHISPER WIRE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2015

Event Type  malfunction  

Event Description

Pt with unstable angina, coronary artery disease, gastric disease, and other conditions underwent coronary intervention.Three non-medicated stents placed into cardiac artery, overlapped due to recurring distal edge dissections.Wire tip sheared off, along with a long polymer coating which extends from the om into the circumflex, down the left main into the aorta.Discharged, returned to hospital (b)(6) with chest pain.Notes include long term risk of thrombosis related to the polymer coating.

• Brand Name: WHISPER WIRE
• Type of Device: WHISPER WIRE
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 4802259
• MDR Text Key: 5921373
• Report Number: MW5042842
• Device Sequence Number: 1
• Product Code: DQX
• 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: 05/21/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR