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

Model Number	H7493941812250
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.
Event or Problem Description
It was reported that the device moved on the balloon.The target lesion was located in a coronary artery.A 2.50 x 12mm synergy xd drug-eluting stent was advanced for treatment, but it could not be delivered.However, it was noticed that the stent was loose on the balloon.The procedure was completed with a different device.There was no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.50 x 12mm stent delivery system (sds) was returned to the complaint investigation site (cis).A visual and tactile examination identified no issue or damages in the hypotube profile and stent profile.A microscopic examination of stent has no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No issues identified with the outer / mid-shaft sections or the inner lumen of the device.Bumper tip showed no signs of distal tip damage.The crimped stent outer diameter was measured by snap gauge and the result was within max crimped stent profile measurement.The device could be loaded on a guidewire without issues.B3: date of event: used first date of the month since exact event date was not provided.
Event or Problem Description
It was reported that moved on balloon occurred.The target lesion was located in a coronary artery.A 2.50 x 12mm synergy xd drug-eluting stent was advanced for treatment, but it could not be delivered.However, it was noticed that the stent was loose on the balloon.The procedure was completed with a different device.There was 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: 22365863
• Report Number: 2124215-2025-42101
• Device Sequence Number: 8288726
• Product Code: NIQ
• UDI-Device Identifier: 08714729980797
• UDI-Public: (01)08714729980797(17)260730(10)34616133
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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
• Report Date (Section B): 08/11/2025

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: 07/30/2026
• Device Model Number: H7493941812250
• Device Catalogue Number: H7493941812250
• Device Lot Number: 0034616133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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