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

Model Number	H7493941816250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Restenosis (4576)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 80% in-stent restenosis and non-st segment elevation myocardial infarction occurred.In (b)(6) 2022, a 2.5 mm x 16 mm synergy xd drug eluting stent was implanted in the proximal left circumflex artery (lcx).In (b)(6) 2026, the patient presented to the hospital and was diagnosed with non-st segment elevation myocardial infarction (nstemi).Coronary angiography revealed 80% in-stent restenosis (isr) in the proximal lcx and revascularization was recommended.The 80% isr in the proximal lcx was successfully treated with balloon angioplasty and a drug-eluting stent.Post revascularization, 0% residual stenosis was noted with timi flow of 3.The patient was discharged.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.

• Brand Name: SYNERGY? XD
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25079684
• Report Number: 2124215-2026-24167
• Device Sequence Number: 10418430
• Product Code: NIQ
• UDI-Device Identifier: 08714729980803
• UDI-Public: (01)08714729980803
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/16/2026

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 Model Number: H7493941816250
• Device Catalogue Number: H7493941816250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 07/16/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Race: White