MAUDE Adverse Event Report: ABBOTT EVEROLIMUS ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number	1125300-15
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
During a percutaneous coronary intervention a stent became dislodged off the delivery system.The delivery system was advanced and removed multiple times attempting to cross the lesion.The stent was successfully retrieved with a snare.

• Brand Name: EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT; santa clara CA 95054
• MDR Report Key: 6701154
• Report Number: MW5070899
• Device Sequence Number: 13712729
• Product Code: NIQ
• UDI-Device Identifier: 08717648199349
• UDI-Public: (01)08717648199349
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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: 11/16/2019
• Device Model Number: 1125300-15
• Device Catalogue Number: 1125300-15
• Device Lot Number: 6111041
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 81