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

Model Number	10618
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	08/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient identifier: (b)(6).Date of event was estimated based on the aware date and the death occurring two months previously.
Event or Problem Description
Evolve lv xlv study.It was reported that the subject died.In (b)(6) 2020, the subject was referred for cardiac catheterization and on the same day index procedure was performed.The 80% stenosed, 4.50 x 16mm, target lesion was located in proximal left circumflex artery (lcx) and had timi flow of 2.The target lesion was treated with pre-dilation and placement of 4.50 mm x 16 mm study stent.Following post-dilation, residual stenosis was noted to be 0% with timi flow of 3.On the following day, the subject was discharged on dual antiplatelet therapy.On an unknown date, the subject expired.During the scheduling of the two-year study specific follow up, the site had contacted the subject's son and was informed that the subject had oral cancer and expired around 2 months previously.
Additional Manufacturer Narrative
B2 date of death: used the first day of the month of august 2022, as death date was unknown.(conservatively captured as (b)(6)2022 as per case entry conventions).A1: patient identifier: (b)(6).B3 date of event was estimated based on the aware date and the death occurring two months previously.
Event or Problem Description
Evolve lv xlv study it was reported that the subject died.In september 2020, the subject was referred for cardiac catheterization and on the same day index procedure was performed.The 80% stenosed, 4.50 x 16mm, target lesion was located in proximal left circumflex artery (lcx) and had timi flow of 2.The target lesion was treated with pre-dilation and placement of 4.50 mm x 16 mm study stent.Following post-dilation, residual stenosis was noted to be 0% with timi flow of 3.On the following day, the subject was discharged on dual antiplatelet therapy.On an unknown date, the subject expired.During the scheduling of the two-year study specific follow up, the site had contacted the subject's son and was informed that the subject had oral cancer and expired around 2 months previously.It was further reported that in 2022, the subject underwent surgery for his oral cancer however, the subject never woke up from the surgery and expired due to unknown cause.It was further reported that in august 2022, the subject died.Additionally, there were no history of cancer noted at the time of enrollment.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).B3 date of event was estimated based on the aware date and the death occurring two months previously.
Event or Problem Description
Evolve lv xlv study it was reported that the subject died.In september 2020, the subject was referred for cardiac catheterization and on the same day index procedure was performed.The 80% stenosed, 4.50 x 16mm, target lesion was located in proximal left circumflex artery (lcx) and had timi flow of 2.The target lesion was treated with pre-dilation and placement of 4.50 mm x 16 mm study stent.Following post-dilation, residual stenosis was noted to be 0% with timi flow of 3.On the following day, the subject was discharged on dual antiplatelet therapy.On an unknown date, the subject expired.During the scheduling of the two-year study specific follow up, the site had contacted the subject's son and was informed that the subject had oral cancer and expired around 2 months previously.It was further reported that in 2022, the subject underwent surgery for his oral cancer however, the subject never woke up from the surgery and expired due to unknown cause.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15621603
• Report Number: 2124215-2022-41992
• Device Sequence Number: 6499285
• Product Code: NIQ
• UDI-Device Identifier: 08714729973355
• UDI-Public: 08714729973355
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 03/01/2023

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: 10/13/2021
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0024655945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 10/27/2022; 02/22/2023
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/01/2022; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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: 63 YR
• Patient Sex: Male
• Patient Race: White