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	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a coronary artery.A 2.50x38mm synergy drug-eluting stent was advanced for treatment.However, it was noted that the stent came off the balloon.The stent was dislodged in a proximal vessel.A smaller balloon was inserted and crushed the dislodged stent against the vessel wall and completed the procedure.No patient complications were reported.
Additional Manufacturer Narrative
The device is a combination product.Updates made to: describe event or problem, implant date.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a coronary artery.A 2.50x38mm synergy drug-eluting stent was advanced for treatment.However, it was noted that the stent came off the balloon.The stent was dislodged in a proximal vessel.A smaller balloon was inserted and crushed the dislodged stent against the vessel wall and completed the procedure.No patient complications were reported.Voluntary medwatch/maude report # mw5082039.

• 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: 8261448
• Report Number: 2134265-2018-65203
• Device Sequence Number: 11282853
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0021726930
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/18/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention