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

Model Number	10606
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Event date: the event date was note reported.Used (b)(6) 2019 as event date since the correct date was not provided.
Event or Problem Description
It was reported that the stent moved on balloon.The target lesion was located in the severely tortuous and mildly calcified mid right coronary artery.A 3.00x32mm synergy drug-eluting stent was advanced but failed to cross the lesion.Pre-dilatation was performed and the device was able to cross the lesion but when the physician pulled the device slightly to fully cover the lesion, the device was pulled too far and could not be advanced further.Pre-dilatation was again performed and a non-bsc extension catheter was used to aid in crossing the lesion.The device was able to cross and was inflated to nominal pressure.The balloon looked great on x-ray but when the delivery system was removed, the stent was still on the balloon, crunched back to the proximal end of the balloon.The device was completely removed and the procedure was completed with a new stent.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: 9397714
• Report Number: 2134265-2019-14754
• Device Sequence Number: 2708187
• Product Code: NIQ
• UDI-Device Identifier: 08714729840350
• UDI-Public: 08714729840350
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/02/2019

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 Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0024272496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1