MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10607
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was stripped off from the balloon.The target lesion was in the coronary artery.A 3.00x38 synergy drug eluting stent and a guidezilla ii guide extension catheter were selected for use in a percutaneous coronary intervention (pci).During the procedure, it was noted that the stent was stripped off from the balloon at the collar of the guidezilla.The stent delivery system was then removed to the collar of the guidezilla and were removed together.However, a crack at the collar of the guidezilla was noted after removal.There were no device fragments left inside the patient's body and the procedure was completed with a different device.There were no patient complications reported.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9903237
• Report Number: 2134265-2020-04099
• Device Sequence Number: 754907
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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): 03/31/2020

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: 09/02/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024416686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1