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

Model Number	H7493942824400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Death
Event or Problem Description
Evolve lv xlv study it was reported that a patient death occurred.On (b)(6) 2021, the subject presented with stable angina and the index procedure was performed on the same day.The 90% stenosed target lesion as located in the mid right coronary artery (rca) and was 16mm long, with a reference vessel diameter of 4mm.The lesion was treated with predilation and placement of 4.00mm x 24mm and 4.00mm x 28mm study stents.Following post dilatation, residual stenosis was 0%.Non target lesions were also treated.The ramus lesion was treated with the placement of a 2.50mm x 24mm synergy stent.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2021, a staged procedure was performed.The non target lesion located in the proximal left anterior descending artery (lad) and mid lad were treated using 3.00mm x 38mm synergy and 3.50mm x 32mm synergy stents in an overlapping fashion.On (b)(6) 2021, the subject expired due to unknown cause outside the hospital.In response to the event, no action or diagnostics were performed.It is unknown whether an autopsy was performed.
Event or Problem Description
Evolve lv xlv study it was reported that a patient death occurred.On( b)(6) 2021, the subject presented with stable angina and the index procedure was performed on the same day.The 90% stenosed target lesion as located in the mid right coronary artery (rca) and was 16mm long, with a reference vessel diameter of 4mm.The lesion was treated with predilation and placement of 4.00mm x 24mm and 4.00mm x 28mm study stents.Following post dilatation, residual stenosis was 0%.Non target lesions were also treated.The ramus lesion was treated with the placement of a 2.50mm x 24mm synergy stent.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2021, a staged procedure was performed.The non target lesion located in the proximal left anterior descending artery (lad) and mid lad were treated using 3.00mm x 38mm synergy and 3.50mm x 32mm synergy stents in an overlapping fashion.On (b)(6) 2021, the subject expired due to unknown cause outside the hospital.In response to the event, no action or diagnostics were performed.It is unknown whether an autopsy was performed.It was further reported that the patient passed away at home.
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).Correction: h6: evaluation code: from: cause not established d15.To: known inherent risk of device d12.
Event or Problem Description
Evolve lv xlv study.It was reported that a patient death occurred.On (b)(6) 2021, the subject presented with stable angina and the index procedure was performed on the same day.The 90% stenosed target lesion as located in the mid right coronary artery (rca) and was 16mm long, with a reference vessel diameter of 4mm.The lesion was treated with predilation and placement of 4.00mm x 24mm and 4.00mm x 28mm study stents.Following post dilatation, residual stenosis was 0%.Non target lesions were also treated.The ramus lesion was treated with the placement of a 2.50mm x 24mm synergy stent.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2021, a staged procedure was performed.The non target lesion located in the proximal left anterior descending artery (lad) and mid lad were treated using 3.00mm x 38mm synergy and 3.50mm x 32mm synergy stents in an overlapping fashion.On (b)(6) 2021, the subject expired due to unknown cause outside the hospital.In response to the event, no action or diagnostics were performed.It is unknown whether an autopsy was performed.It was further reported that the patient passed away at home.It was further reported that the cause of death was due to cardiac arrest, and it was corrected that the patient did not pass away at home.
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 presented with stable angina and the index procedure was performed on the same day.The 90% stenosed target lesion as located in the mid right coronary artery (rca) and was 16mm long, with a reference vessel diameter of 4mm.The lesion was treated with predilation and placement of 4.00mm x 24mm and 4.00mm x 28mm study stents.Following post dilatation, residual stenosis was 0%.Non target lesions were also treated.The ramus lesion was treated with the placement of a 2.50mm x 24mm synergy stent.On the same day, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2021, a staged procedure was performed.The non target lesion located in the proximal left anterior descending artery (lad) and mid lad were treated using 3.00mm x 38mm synergy and 3.50mm x 32mm synergy stents in an overlapping fashion.On 10 december 2021, the subject expired due to unknown cause outside the hospital.In response to the event, no action or diagnostics were performed.It is unknown whether an autopsy was performed.It was further reported that the patient passed away at home.It was further reported that the cause of death was due to cardiac arrest, and it was corrected that the patient did not pass away at home.

• 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: 13087787
• Report Number: 2134265-2021-16105
• Device Sequence Number: 5734644
• Product Code: NIQ
• UDI-Device Identifier: 08714729985709
• UDI-Public: 08714729985709
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 02/21/2022

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: 11/30/2021
• Device Model Number: H7493942824400
• Device Lot Number: 0026480719
• 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: 12/14/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 01/25/2022; 02/18/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/19/2022; 02/14/2022; 02/21/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: White