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

Model Number	10601
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 3.50 x 12mm synergy ii drug eluting stent was advance, but could not pass the lesion initially.When the device was removed to do more pre-dilatation, it was noticed that a stent strut was damage.The procedure was completed with a new 3.5x12 stent.There were no patient complications reported.
Additional Manufacturer Narrative
B5 describe event or problem updated.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left anterior descending artery.A 3.50 x 12mm synergy ii drug eluting stent was advance for treatment but the stent would not pass the lesion initially.However, after removal, it was found that the stent strut was damage.The procedure was completed with a different device.Ther were no patient complications reported.It was further reported that the target lesion was 80% stenosed and was mildly tortuous and mildly calcified.

• 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: 10605022
• Report Number: 2134265-2020-13513
• Device Sequence Number: 2941284
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: 08714729840060
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/04/2020

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: 11/03/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0024792846
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR