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

Model Number	10604
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the coronary artery.A 3.00 x 24mm synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent struts were chewed up.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the coronary artery.A 3.00 x 24mm synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent struts were chewed up.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.It was further reported that there was a 90 degree bend prior to the target lesion in the circumflex.A guide extension was used to provide assistance but on the first try the physician only took it to the bend and not past it.The stent was removed and noted to be damaged.Another of the same size was opened and on that attempt the guide extension was advanced further down past the bend and the stent was easily delivered.
Additional Manufacturer Narrative
Device is a combination product.

• 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: 9836836
• Report Number: 2134265-2020-02797
• Device Sequence Number: 13778002
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 04/07/2020

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: 09/11/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024466198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1