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

Model Number	10602
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	12/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an adverse event occurred.The target lesion was located in a coronary artery.A 3.00 x 16 synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the device was unable cross the lesion and it caused a significant delay to the procedure that resulted in an adverse patient event.No further information is available at this time.
Event or Problem Description
It was reported that an adverse event occurred.The target lesion was located in the coronary artery.A 3.00 x 16 synergy drug-eluting stent was advanced for treatment.However, during procedure, device was unable cross the lesion and it caused a significant delay to the procedure that resulted in an adverse patient event.No further information available at this time.It was further reported that the inability to cross the lesion did not cause a significant delay to the procedure that resulted in an adverse patient event.The procedure was completed with no patient complications.

• 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: 11011661
• Report Number: 2134265-2020-17687
• Device Sequence Number: 17042767
• Product Code: NIQ
• UDI-Device Identifier: 08714729840114
• UDI-Public: 08714729840114
• 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): 01/04/2021

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: 11/06/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024781440
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/04/2021
• 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: Other