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

Model Number	10606
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent moved on the balloon.A synergy ii des stent was selected for a chronic total occlusion (cto) intervention.During the procedure, after pre-dilatation, a 2.5x38mm synergy stent was placed in the ostial to mid segment (om1).Following this deployment, multiple balloons (1.0mm, 2.0mm, and 3.0mm) were inflated in the proximal circumflex in preparation for stent delivery.A 6f guideliner was inserted to assist in the delivery of the 3.0x32 synergy stent.The 3.0x32 synergy stent was inserted and unable to fully advance across the lesion.When the device was pulled back by the physician, it was noted that the distal 5mm of the stent had been tripped beyond the stent balloon.A 3.0x20 emerge stent was inserted into the guide catheter to trap the stent and remove it.This was not successful.The physician pulled on the stent delivery system again and was able to remove the stent and delivery system entirely together.No further stent was attempted to be delivered.

• 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: 8139211
• Report Number: 2134265-2018-63666
• Device Sequence Number: 203894
• Product Code: NIQ
• UDI-Device Identifier: 08714729840350
• UDI-Public: 08714729840350
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/06/2018

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: 08/12/2020
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0022544921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/06/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.0X20 EMERGE STENT; 6F GUIDELINER
• Patient Age: 57 YR