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

Model Number	H7493941828350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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 3.50 x 28mm 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 3.50 x 28mm 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 3.50 x 28mm stent delivery system was returned to the complaint investigation site for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube shaft identified a break at 19cm distal to the distal end of the strain relief and multiple hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section identified no issues.There was no sign of damage, stretching or lifting of the stent struts.Balloon material was reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed signs of 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: 22171182
• Report Number: 2124215-2025-37751
• Device Sequence Number: 9520199
• Product Code: NIQ
• UDI-Device Identifier: 08714729981077
• UDI-Public: (01)08714729981077(17)260610(10)34290878
• 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): 07/24/2025

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: 06/10/2026
• Device Model Number: H7493941828350
• Device Catalogue Number: H7493941828350
• Device Lot Number: 0034290878
• 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: 07/09/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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