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

Model Number	H7493941816300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodge occurred requiring additional intervention.The target lesion was located in the coronary artery.A non-bsc guide catheter was inserted.Prior to balloon inflation, a 3.00 x 16mm synergy? xd drug-eluting stent was advanced to treat the lesion, however; the stent came off the balloon and could not be removed.No pressure had been applied to the balloon before the stent detached.An attempt was made to snare the stent, but this was unsuccessful, and the stent was ultimately deployed into the left main coronary artery.The procedure was completed.There were no patient complications reported and the patient fully recovered.

• 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: 23696912
• Report Number: 2124215-2025-87807
• Device Sequence Number: 13334207
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: (01)08714729980964(17)270107(10)35641887
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493941816300
• Device Catalogue Number: H7493941816300
• Device Lot Number: 0035641887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 01/07/2025
• 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: Required Intervention
• Patient Sex: Unknown