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

Model Number	10607
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Event date estimated at (b)(6) 2019 as it was reported the event occurred the wednesday or thursday of the week prior to (b)(6) 2019.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the ostial right coronary artery.A 4.00x38mm synergy stent was used to treat the lesion.However, while advancing, the device got stuck at the tip of the guide catheter.When the guide and the device were removed, it was noticed that the stent was off the balloon and in the guide.The procedure was completed after replacing both devices.No patient complications were reported and the patient was fine.

• 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: 8367628
• Report Number: 2134265-2019-01616
• Device Sequence Number: 1587821
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 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: 09/10/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0022680211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Initial 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