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

Model Number	H7493941812300
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 3.00 x 12mm stent delivery system was returned for analysis.Visual, tactile, and microscopic analysis was performed on the device.A visual and tactile inspection of hypotube identified multiple kinks.Visual and tactile inspection of the shaft polymer extrusion revealed a kink, 2.5 cm from the guidewire exit port.The stent returned detached from balloon, and it was stretched.A detailed microscopic examination of the balloon identified crimped stent marks however the balloon did not appear to have been subjected to positive pressure and there were no tears or pinholes identified in the balloon material.A microscopic examination of the proximal and distal markerbands identified no damage.Distal tip damage (dented) was observed.
Event or Problem Description
Reportable based on device analysis completed on 09dec2025.It was reported that crossing difficulties were encountered.The patient presented with coronary artery disease and underwent percutaneous transluminal coronary angioplasty.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.Following pre-dilatation with 2.5 x 12mm balloon catheter, a 3.00 x 12mm synergy xd drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.There were no patient complications, and the patient condition was stable post-procedure.However, returned device analysis revealed that stent was detached.

• 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: 23956995
• Report Number: 2124215-2026-00250
• Device Sequence Number: 14887764
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: (01)08714729980957(17)270325(10)36259094
• Combination Product (Y/N): Y
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2026

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: H7493941812300
• Device Catalogue Number: H7493941812300
• Device Lot Number: 0036259094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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 Sex: Unknown