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

Model Number	H7493941848300
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.00 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, physician noticed a kink in the shaft of the stent and when he pulled it out, the shaft broke.Both pieces were removed and completed the procedure with a different device.There were no patient complications reported.
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.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.00 x 48mm stent delivery system (sds) was returned to the complaint investigation site (cis).A visual and tactile examination of the hypotube shaft identified a break 19.8cm distal to the distal end of the strain relief and multiple hypotube kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination revealed no sign of damage, stretching or lifting of the stent struts the balloon material identified no tears or pinholes in the balloon.Bumper tip showed no signs of distal tip damage.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.The target lesion was located in a coronary artery.A 3.00 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, physician noticed a kink in the shaft of the stent and when he pulled it out, the shaft broke.Both pieces were removed and completed the procedure 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: 21809108
• Report Number: 2124215-2025-22129
• Device Sequence Number: 8799214
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: (01)08714729985228(17)261001(10)35045451
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 07/15/2025

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: H7493941848300
• Device Catalogue Number: H7493941848300
• Device Lot Number: 0035045451
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 07/15/2025
• 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