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

Model Number	10619
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/20/2021
Type of Reportable Event	Death
Event or Problem Description
(b)(6) study.It was reported that the patient died.In (b)(6) 2020, the subject was referred for cardiac catheterization and on the same day index procedure was performed.Target lesion 1 was located in left main coronary artery (lmca) with 85 % stenosis and was 18 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 20 mm study stent.Following post-dilatation, residual stenosis was 0 % with timi flow 3.On the following day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2021, post index procedure, subject expired due to sudden cardiac death and in response to the event no action was taken and autopsy was not performed.
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Additional Manufacturer Narrative
B5: describe event or problem updated.A1: patient identifier: (b)(6).
Event or Problem Description
Evolve_lv_xlv.It was reported that the patient died.On (b)(6) 2020, the subject was referred for cardiac catheterization and on the same day index procedure was performed.Target lesion 1 was located in left main coronary artery (lmca) with 85 % stenosis and was 18 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with pre-dilatation and placement of a 4.50 mm x 20 mm study stent.Following post-dilatation, residual stenosis was 0 % with timi flow 3.On the following day, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2021, post index procedure, subject expired due to sudden cardiac death and in response to the event no action was taken and autopsy was not performed.It was further reported that, during the time of death, the subject was not in the hospital and it was unknown whether the subject was under hospice care.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13471886
• Report Number: 2134265-2022-00848
• Device Sequence Number: 4870966
• Product Code: NIQ
• UDI-Device Identifier: 08714729973362
• UDI-Public: 08714729973362
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 10/20/2021
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0024711866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: White