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

Model Number	H7493942816400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2021
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 patient death occurred.On (b)(6) 2021, the subject was enrolled in the megatron cohort of the evolve lv xlv study and on the same day index procedure was performed.Target lesion was located in proximal lad (cass site #12) with 90% stenosis and was 12 mm long with a reference vessel diameter of 4.5 mm.The target lesion was treated with direct placement of a 4.00 mm x 16 mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2021, the subject was discharged on aspirin.On (b)(6) 2021 202 days post index procedure, subject expired due to unknown event circumstance and in response to the event no action was taken or diagnostics were performed.The subject passed away.It is unknown whether autopsy was performed or not.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).
Event or Problem Description
Evolve lv xlv study it was reported that a patient death occurred.On (b)(6) 2021, the subject was enrolled in the megatron cohort of the evolve lv xlv study and on the same day index procedure was performed.Target lesion was located in proximal lad (cass site #12) with 90% stenosis and was 12 mm long with a reference vessel diameter of 4.5 mm.The target lesion was treated with direct placement of a 4.00 mm x 16 mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2021, the subject was discharged on aspirin.On (b)(6) 2021, 202 days post index procedure, subject expired due to unknown event circumstance and in response to the event no action was taken or diagnostics were performed.The subject passed away.It is unknown whether autopsy was performed or not.It was further reported that the primary cause was death was due to multiple diseases of aging which was a consequence of coronary artery disease and copd per death certificate.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12964323
• Report Number: 2134265-2021-15598
• Device Sequence Number: 5409744
• Product Code: NIQ
• UDI-Device Identifier: 08714729985624
• UDI-Public: 08714729985624
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 12/21/2021

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: 11/30/2021
• Device Model Number: H7493942816400
• Device Lot Number: 0026485371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Race: White