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

Model Number	10606
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that stent damage occurred.A bmw wire attempted to cross a 2.50 x 32mm synergy us mr stent through the left main into the ositial circumflex (cx), however, the stent was unable to advance due to an unknown stent hanging out of the left anterior descending coronary artery (lad).When the synergy stent was removed, it was noticed that the stent had damage to the struts.A 2.5 x 12 emerge balloon was advanced into the osital circumflex (cx) and was inflated.A new second stent was crossed into the lesion and was deployed without incident.No patient complications were reported and the patient was in stable condition.

• 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: 7923664
• Report Number: 2134265-2018-61478
• Device Sequence Number: 1787275
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/01/2018

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: 03/05/2019
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0021852594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/01/2018
• Patient Sequence Number: 1