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

Model Number	H7493941808270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.75 x 8mm synergy xd drug-eluting stent was advanced for treatment.However, the proximal shaft of the stent broke when going into the wire.The device was removed off the wire and completed the procedure with another of same device.There were no patient complications.
Event or Problem Description
It was reported that shaft break occurred.A 2.75 x 8mm synergy xd drug-eluting stent was advanced for treatment.However, the proximal shaft of the stent broke when going into the wire.The device was removed off the wire and completed the procedure with another of same device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.75 x 8mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at 76.2cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section identified no issues.Microscopic analysis revealed that there was no sign of damage, stretching or lifting of the stent struts.Balloon material was reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed signs of damage.A microscopic examination of the proximal and distal markerbands identified no damage.

• 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: 24042611
• Report Number: 2124215-2026-01891
• Device Sequence Number: 10482750
• Product Code: NIQ
• UDI-Device Identifier: 08714729980865
• UDI-Public: (01)08714729980865(17)270127(10)35789458
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: H7493941808270
• Device Catalogue Number: H7493941808270
• Device Lot Number: 0035789458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/05/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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