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

Model Number	10601
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.After performing rotational atherectomy in the left anterior descending artery, forte guidewire was inserted to take place the rota wire.A 3.00 x 12 synergy drug-eluting stent was used to treat the lesion.However, it was unable to advance over the guidewire due to lack of guide catheter support.They tried to pullout the device, but the stent would not come off the wire.The physician removed both wire and the stent together from the patient.The procedure was completed with another of the same device.No patient complications nor injuries 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: 7944502
• Report Number: 2134265-2018-61648
• Device Sequence Number: 11141352
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: 08714729840053
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 06/25/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022320660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1