MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10619
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent became damaged during withdrawal through the guide extension catheter.A 6fr guidezilla ii and a 5x20 synergy stent were selected for use for a coronary intervention procedure in the right coronary artery.During the procedure, a lot of resistance was felt advancing the stent through the guidezilla.The physician attempted to pull the stent out of the guidezilla, but the stent struts became damaged.The stent remained on the delivery balloon, however, the balloon was stick in the guidezilla.The physician then removed everything from the patient.The physician thought that the 5x20 synergy was too large to fit through the guidezilla.The procedure was completed by using a new guidezilla and a smaller stent.There were no patient complications reported and the patient was fine post procedure.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8627473
• Report Number: 2134265-2019-05532
• Device Sequence Number: 11304801
• Product Code: NIQ
• UDI-Device Identifier: 08714729973447
• UDI-Public: 08714729973447
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2019

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: 11/04/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0022917702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1