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

Model Number	H7493942816450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Restenosis (4576)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
Evolve lv xlv study: it was reported that restenosis occurred.On (b)(6) 2022, the subject's qualifying condition was stable angina (ccs classification: 1).The subject , the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The 80% stenosed target lesion was located in the proximal left circumflex (lcx) and was 12 mm long, with a reference vessel diameter of 4.5mm and timi flow of 3.The lesion was treated with direct placement of a 4.50 mm x 16 mm study stent.Following post dilatation, residual stenosis was 0% with timi flow of 3.On the same day, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2022, the subject was noted with dyspnea and infrequent chest tightness.The symptoms were worsened with exertion.On (b)(6) 2022, the subject visited the hospital for a planned left heart catheterization (lhc) for complaints of dyspnea and chest pain on exertion concerning for ccs 3 angina.Subsequently, left coronary angiography was performed which revealed a luminal diseased left main coronary artery (lmca), a patent proximal stent and an 80% stenosed mid left anterior descending artery (lad), a 20% in stent restenosed diagonal artery, a 95% in stent restenosed in the ostial left circumflex (lcx), a 70% stenosed ostial ramus intermedius, and a 40% stenosed non dominant proximal right coronary artery (rca).Based on these findings, the subject was recommended for coronary artery bypass surgery of the left internal mammary artery (lima) to left anterior descending artery (lad), saphenous vein graft (svg) to ramus intermedius (ri) coronary artery, and svg to lcx on (b)(6) 2022 and was also advised to continue aspirin, statin, losartan and coreg.On (b)(6) 2022, the subject revisited the hospital for the planned bypass surgery and was hospitalized on the same day for the further medical evaluation.Bypass surgery of lima to lad, svg to diagonal branch and svg to obtuse marginal branch were performed.The event is considered as not recovered/resolved.

• 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: 14758814
• Report Number: 2134265-2022-07123
• Device Sequence Number: 6022749
• Product Code: NIQ
• UDI-Device Identifier: 08714729985631
• UDI-Public: 08714729985631
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/21/2022

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: H7493942816450
• Device Lot Number: 0026492863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/21/2022
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: Black Or African American