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

Model Number	10604
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Used (b)(6) 2019 as event date as there was no date provided.
Event or Problem Description
It was reported that shaft break occurred.A 2.50x24mm synergy stent was used in a procedure.However, the shaft got fractured when the stent was deployed.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 2.50x24mm synergy stent was used in a procedure.However, the shaft got fractured when the stent was deployed.No patient complications were reported.It was further reported that the device was completely removed through the guide.The procedure was completed with a non-bsc stent and the patient was discharged afterwards.
Additional Manufacturer Narrative
Device is a combination product.Used (b)(6) 2019 as event date as there was no date provided.

• 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: 8286840
• Report Number: 2134265-2019-00505
• Device Sequence Number: 19250648
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• 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): 02/25/2019

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 Expiration Date: 09/03/2020
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0022650373
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1