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

Model Number	H7493942832350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
Evolve lv xlv study.It was reported that a subject death occurred.(b)(6) 202, revealed subject qualifying condition was myocardial infarction and stable angina (ccs classification: hence, the subject was referred to cardiac catheterization.The same day the index procedure was performed.Target lesion 1 was located in left main coronary artery with 95% stenosis and was 25 mm long with a reference vessel diameter of 4 mm.Target lesion 1 was treated with pre dilation and placement of 3.50 mm x 32 mm study stent.Following post dilation, residual stenosis was noted to be 0% with timi flow 3.Additionally a non-target lesion was also treated.Non-target lesion 1 was located in proximal left circumflex artery (lcx) and was treated with placement of 3.00 mm x 38 mm synergy stent.On 09july2021, subject was discharged on dual antiplatelet therapy.On 15march2022, 251 days post index procedure, subject expired due to unknown cause of death.
Event or Problem Description
Evolve lv xlv study.It was reported that a subject death occurred.(b)(6) 2022, revealed subject qualifying condition was myocardial infarction and stable angina (ccs classification: 2).Hence, the subject was referred to cardiac catheterization.The same day the index procedure was performed.Target lesion 1 was located in left main coronary artery with 95% stenosis and was 25 mm long with a reference vessel diameter of 4 mm.Target lesion 1 was treated with pre dilation and placement of 3.50 mm x 32 mm study stent.Following post dilation, residual stenosis was noted to be 0% with timi flow 3.Additionally a non-target lesion was also treated.Non-target lesion 1 was located in proximal left circumflex artery (lcx) and was treated with placement of 3.00 mm x 38 mm synergy stent.On (b)(6) 2021, subject was discharged on dual antiplatelet therapy.On (b)(6) 2022, 251 days post index procedure, subject expired due to unknown cause of death.It was further reported that the subject expired due to failure to thrive as consequence of dysphagia and cerebrovascular disease.
Additional Manufacturer Narrative
A1: patient identifier - (b)(6).

• Brand Name: SYNERGY MEGATRON
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14776619
• Report Number: 2134265-2022-07169
• Device Sequence Number: 1349367
• Product Code: NIQ
• UDI-Device Identifier: 08714729985778
• UDI-Public: 08714729985778
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/15/2022

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: 12/02/2021
• Device Model Number: H7493942832350
• Device Lot Number: 0026505660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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 Sex: Male
• Patient Race: White