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

Model Number	10607
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment and shaft break occurred.Vascular access was obtained via femoral access.The target lesion was located in the mid to distal right coronary artery (rca).After a 1.50 rotablator was advanced and initially burred the lesion, a 2.50 x 38 synergy ii stent was advanced through the proximal rca with the aid of a 6f non-bsc extension catheter in an 8f guide catheter but the device failed to cross.When the stent delivery system (sds) was pulled out, it was noted that the stent was not on the sds.The stent had come off and was inside the guide.Upon checking further, it was noted that the shaft was broken.The physician was able to retrieve the stent from the guide.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: 8182375
• Report Number: 2134265-2018-64557
• Device Sequence Number: 19311500
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/19/2018

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: 07/03/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0022366082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1