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	10/21/2019
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 right coronary artery.A 2.50x24mm synergy ii drug-eluting stent was advanced for treatment.However, the device would not pass through a previously deployed synergy stent and it was noticed that a strut got caught.The device was removed and the procedure was completed with a non-bsc device.No patient complications were reported.The patient was well.
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 right coronary artery.A 2.50x24mm synergy ii drug-eluting stent was advanced for treatment.However, the device would not pass through a previously deployed synergy stent and it was noticed that a strut got caught.The device was removed and the procedure was completed with a non-bsc device.No patient complications were reported.The patient was well.It was further reported that the 75% stenosed target lesion with a bend of <45 degrees was located in the moderately calcified rca.Pre-dilatation and post-dilatation was also performed in the lesion.

• 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: 9282980
• Report Number: 2134265-2019-13428
• Device Sequence Number: 11299111
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/05/2019

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 Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022650373
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1