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

Model Number	H7493941816350
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
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 via user medwatch mw5179553 that stent damaged post-deployment occurred.The patient underwent percutaneous coronary intervention (pci).A 3.50 x 16mm synergy xd drug-eluting stent (des) was deployed, but a stent strut fracture was noted post-deployment.A second 3.50 x 16mm synergy xd des was then placed; however, another post-deployment stent strut fracture occurred.There were no patient complications reported.
Additional Manufacturer Narrative
H6.Device codes corrected.
Event or Problem Description
It was reported via user medwatch mw5179553 that stent fracture occurred.The patient underwent percutaneous coronary intervention (pci).A 3.50 x 16mm synergy xd drug-eluting stent (des) was deployed, but a stent strut fracture was noted post-deployment.A second 3.50 x 16mm synergy xd des was then placed; however, another post-deployment stent strut fracture occurred.There were no patient complications reported.

• 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: 24048093
• Report Number: 2124215-2026-02033
• Device Sequence Number: 18578134
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: (01)08714729981046(17)270107(10)35669706
• 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
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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 Model Number: H7493941816350
• Device Catalogue Number: H7493941816350
• Device Lot Number: 0035669706
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/16/2026
• 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
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White