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

Lot Number	0026472179
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Angina (1710)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).
Event or Problem Description
Evolve_lv_xlv clinical study it was reported that angina recurred.In (b)(6) 2021, the subject qualifying condition was stable angina and the subject was referred for cardiac catheterization.The index procedure was performed on the next day.The first target lesion was located in the distal right coronary artery (rca) with 80% stenosis and was 12 mm long with a reference vessel diameter of 4.0 mm.The first target lesion was treated with pre-dilation and placement of a 3.50 mm x 16mm stent.Following post-dilation, residual stenosis was noted to be 0% with timi flow 3.The second target lesion was located in the mid rca with 80% stenosis and was 28 mm long with a reference vessel diameter of 4.0 mm.The second target lesion was treated with pre-dilation and placement of a 3.50 mm x 32 mm stent.Following post-dilation, residual stenosis was noted to be 20% with timi flow 3.The subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject was noted with symptoms of recurrent class iii angina.The anginal symptoms had been progressive over the past several weeks.The subject had chest burning radiating to the jaw with exertion.The subject had elevated blood pressure upon arising in the morning which could possibly be due to sleep apnea; the rest of the day, their blood pressure got well-controlled.In (b)(6) 2023, the subject underwent percutaneous coronary intervention by placement of non-boston scientific (non-bsc) stent in large calcified and tortuous mid left anterior descending artery (lad) which was complicated by vessel perforation requiring placement of a non-bsc covered stent.On the same day, angiography was performed without revascularization which revealed occluded first obtuse marginal branch and mid rca stents that received collaterals.The subject recovered well from the procedure and was discharged home on the same day.The subject still got dyspneic and had episodes of chest burning on moderate exertion which were relieved with rest.The subject had class ii congestive heart failure with dynspea and trace leg edema.The event was considered not recovered/not resolved.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17711726
• Report Number: 2124215-2023-46799
• Device Sequence Number: 6731095
• Product Code: NIQ
• UDI-Device Identifier: 08714729985617
• UDI-Public: 08714729985617
• 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
• Report Date (Section B): 09/08/2023

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: 11/30/2021
• Device Lot Number: 0026472179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/08/2023
• 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: Other
• Patient Age: 63 YR
• Patient Sex: Male