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

Model Number	H7493941820300
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in a coronary artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, the stent was lifted off the balloon upon inserting into the guide.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in a coronary artery.A 3.00 x 20 mm synergy xd drug-eluting stent was advanced for treatment.However, the stent was lifted off the balloon upon inserting into the guide.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Updated batch/lot # from 0034750140 to 0033524830 to be consistent with the returned device.E1: initial reporter facility name: (b)(6) hospital.
Additional Manufacturer Narrative
Device evaluated by mfr.: a partial synergy xd mr us 3.00 x 20mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break in the hypotube with a 25.5cm section of the hypotube only returned.The distal section including the polymer extrusion, stent, balloon or tip were not returned for analysis.Multiple hypotube kinks were noted on the returned section of the hypotube.The crimped stent outer diameter was measured at the time of manufacturing is within max crimped stent profile measurement.Updated batch/lot # from 0034750140 to 0033524830 to be consistent with the returned device.E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in a coronary artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, the stent was lifted off the balloon upon inserting into the guide.The procedure was completed with a different device.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: 21731040
• Report Number: 2124215-2025-19265
• Device Sequence Number: 4109208
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: (01)08714729980971(17)260218(10)33524830
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2025

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 Expiration Date: 02/18/2026
• Device Model Number: H7493941820300
• Device Catalogue Number: H7493941820300
• Device Lot Number: 0033524830
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 06/16/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/28/2025; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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 Sex: Unknown