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

Model Number	H7493941848350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Myocardial Infarction (1969)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event approximately used as actual date is unknown.
Event or Problem Description
It was reported that the patient experienced a cardiac arrest and myocardial infarction.A synergy xd mr us 3.50 x 48mm was selected for treatment of the target lesion.During the procedure, the patient coded for 30 seconds and needed to be revived.Approximately two months after the use of the synergy stent, the patient experienced a heart attack.

• 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: 22751064
• Report Number: 2124215-2025-47961
• Device Sequence Number: 13151097
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: (01)08714729985235(17)260814(10)34732014
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: 08/14/2026
• Device Model Number: H7493941848350
• Device Catalogue Number: H7493941848350
• Device Lot Number: 0034732014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 08/14/2024
• 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 Sex: Unknown