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

Model Number	H7493941812300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 12mm synergy? xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, it was noticed that the shaft was broken without excessive force.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 12mm synergy? xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, it was noticed that the shaft was broken without excessive force.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device synergy xd mr us 3.00 x 12mm stent delivery system was returned to the complaint site investigation (cis) for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube found multiple kinks along the shaft and a break at 79cm distal to the distal end of the strain relief and multiple hypotube kinks.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.There was no sign of damage, stretching or lifting of the stent struts and tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.

• 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: 22171394
• Report Number: 2124215-2025-37757
• Device Sequence Number: 7828942
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: (01)08714729980957(17)261001(10)35027865
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 07/21/2025

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: 10/01/2026
• Device Model Number: H7493941812300
• Device Catalogue Number: H7493941812300
• Device Lot Number: 0035027865
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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