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

Model Number	H7493941832300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that patient complications occurred requiring additional intervention.In (b)(6) 2026, the 2.75 mm x 26 mm main branch of the bifurcated target lesion located at the mid left anterior descending vessel was pretreated with a 2.5 mm x 15 mm scoring balloon.The lesion was then successfully treated with 3.0 mm x 32 mm synergy xd stent reaching a maximum inflation pressure of 12.In addition, the 2.75 x 15 mm side branch of the bifurcated target lesion located at the 1st diagonal vessel was pretreated with a 2.0 mm x 15 mm scoring balloon.The target lesion was then successfully treated with a non-boston scientific balloon.The patient was discharged from the hospital.In (b)(6) 2026, the patient presented with shortness of breath and chest pain resulting in a prolonged hospitalization.The patient was discharged the next day.Later that month the patient had an interventional procedure of right and left heart catheterization.The event is considered ongoing.

• 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: 25472283
• Report Number: 2124215-2026-31231
• Device Sequence Number: 18718844
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: (01)08714729981008(17)271201(10)38117143
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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: H7493941832300
• Device Catalogue Number: H7493941832300
• Device Lot Number: 0038117143
• 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: 05/25/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 77 KG