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

Model Number	10607
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage and vessel occlusion occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left main coronary artery.A 3.50 x 38 mm synergy ii drug-eluting stent was advanced for treatment.However, it was noted that the stent got caught in the left main and started to unravel.A guidezilla guide extension catheter was advanced over the stent and was able to be removed successfully.Blood flow was momentarily lost in the left main but it was able to be restored with the implantation of another synergy drug-eluting stent.The procedure was completed.No further patient complications were reported and the patient's status was fine.

• 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: 8955508
• Report Number: 2134265-2019-10077
• Device Sequence Number: 2521090
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0022833965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/03/2019
• 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