MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10617
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Device is a combination product.Patient identifier (b)(6).
Event or Problem Description
Evolve 4.5-5.0 clinical study.It was reported that vessel dissection occurred.In (b)(6) 2019, clinical status assessment indicates the patient's qualifying condition as unstable angina.Subsequently, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the left main coronary artery with 85% stenosis and was 4 mm long with a reference vessel diameter of 5.2mm.The lesion was treated with placement of a 5.00x12mm study stent.Following stent placement, a grade b dissection was noted at the distal to target lesion which was treated with an additional stent placement.After post dilatation, residual stenosis was noted 0% with timi 3 flow.One day post procedure, the patient was discharged on dual antiplatelet therapy.
Event or Problem Description
Evolve 4.5-5.0 clinical study.It was reported that vessel dissection occurred.In (b)(6) 2019, clinical status assessment indicates the patient's qualifying condition as unstable angina.Subsequently, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the left main coronary artery with 85% stenosis and was 4 mm long with a reference vessel diameter of 5.2mm.The lesion was treated with placement of a 5.00x12mm study stent.Following stent placement, a grade b dissection was noted at the distal to target lesion which was treated with an additional stent placement.After post dilatation, residual stenosis was noted 0% with timi 3 flow.One day post procedure, the patient was discharged on dual antiplatelet therapy.It was further reported that the dissection extended into the cicumflex and was treated with another 3.5x12mm synergy stent from the distal end of the stent into the ostial portion of the circumflex.
Additional Manufacturer Narrative
(b)(6).Device is a combination product.(b)(6).Describe event or problem updated.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8748687
• Report Number: 2134265-2019-06802
• Device Sequence Number: 1999513
• Product Code: NIQ
• UDI-Device Identifier: 08714729973423
• UDI-Public: 08714729973423
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2020
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0022901575
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/31/2019
• 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
• Patient Age: 68 YR