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

Model Number	H7493941820220
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2025
Type of Reportable Event	Malfunction
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 stent dislodgement occurred.The target lesion was located in the right coronary artery.After a 5.5f non-boston scientific (bsc) guide catheter was engaged and coronary guidewires crossed the lesion, a 2.25 x 20mm synergy xd drug-eluting stent was advanced toward the lesion and became stuck in the guide catheter.The guide catheter, the non-bsc guide extension catheter, the stent, and the coronary guidewires were all removed together from inside the guide.After removal, the devices were disassembled from the guide, and the stent fell off its delivery system with the stent still intact and undamaged.There were no patient complications.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right coronary artery.After a 5.5f non-boston scientific (bsc) guide catheter was engaged and coronary guidewires crossed the lesion, a 2.25 x 20mm synergy xd drug-eluting stent was advanced toward the lesion and became stuck in the guide catheter.The guide catheter, the non-bsc guide extension catheter, the stent, and the coronary guidewires were all removed together from inside the guide.After removal, the devices were disassembled from the guide, and the stent fell off its delivery system with the stent still intact and undamaged.There were no patient complications.It was further reported that the event had been submitted via medwatch report mw5179568.Furthermore, as the procedure continued, the patient was resting comfortably with stable vital signs and no signs of distress.

• 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: 23759653
• Report Number: 2124215-2025-89905
• Device Sequence Number: 15975397
• Product Code: NIQ
• UDI-Device Identifier: 08714729980735
• UDI-Public: (01)08714729980735(17)260416(10)33899628
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2026
• Device Model Number: H7493941820220
• Device Catalogue Number: H7493941820220
• Device Lot Number: 0033899628
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 04/16/2024
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White