MAUDE Adverse Event Report: ABBOTT VASCULAR EVEROLIMUS ELUTING CORONARY STENT SYSTEM 3.5MMX8MM CORONARY DRUG-ELUTING STENT

Lot Number 8092841

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  malfunction  

Event Description

Coronary stent deployed ostial right coronary artery and migrated up around guide catheter. Stent pulled back and relocated and deployed in right brachial artery. Fda safety report id # (b)(4).

• Brand Name: EVEROLIMUS ELUTING CORONARY STENT SYSTEM 3.5MMX8MM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA 95054
• MDR Report Key: 8755362
• MDR Text Key: 150123610
• Report Number: MW5087767
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/07/2019
• Device Lot Number: 8092841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage