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	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the first day of the month of the aware date since event date not provided.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 38 synergy drug-eluting stent was advanced for treatment.However, it was noted that the device failed to cross the lesion and when it was removed, the stent struts were found to be damaged.The procedure was completed with different device.No patient complications were reported and no harm was done to the patient.
Additional Manufacturer Narrative
Device is a combination product.(b3) date of event: updated to (b)(6) 2020.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 38 synergy drug-eluting stent was advanced for treatment.However, it was noted that the device failed to cross the lesion and when it was removed, the stent struts were found to be damaged.The procedure was completed with different device.No patient complications were reported and no harm was done to the patient.

• 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: 9841302
• Report Number: 2134265-2020-03414
• Device Sequence Number: 2886834
• Product Code: NIQ
• UDI-Device Identifier: 08714729840411
• UDI-Public: 08714729840411
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1