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	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 38 synergy drug-eluting stent was selected for treatment.However, it was noted that the stent was damaged when they opened it.The device never entered the patient's body.The procedure was completed using a different device.No patient complications were reported.

• 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: 8552084
• Report Number: 2134265-2019-04385
• Device Sequence Number: 361403
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 04/25/2019

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: 10/16/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0022861163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1