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

Model Number	H7493941832300
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event- used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that shaft break occurred.A 3.0 x 32mm synergy xd des broke on a non-boston scientific wire.
Event or Problem Description
It was reported that shaft break occurred.A 3.0 x 32mm synergy xd des broke on a non-boston scientific wire.
Additional Manufacturer Narrative
B3.Date of event- used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: synergy xd mr us 3.00 x 32mm was returned for analysis.A visual and tactile inspection of the hypotube profile identified a partial device was returned to site, the entire hypotube and manifold were not provided by the customer.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified a break and kinks in the polymer extrusion.A microscopic examination identified a break in the inner lumen 21cm from the tip, the inner lumen was also bunched 7.7cm from the tip and at the proximal markerband.A microscopic analysis of the stent identified no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed under microscopic examination, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip 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: 23351402
• Report Number: 2124215-2025-74456
• Device Sequence Number: 9131034
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: (01)08714729981008(17)270205(10)35796010
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: H7493941832300
• Device Catalogue Number: H7493941832300
• Device Lot Number: 0035796010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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