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

Model Number	H7493941808400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 8mm synergy? xd drug-eluting stent was advanced and inserted over the wire into a non-boston scientific guide.However, the shaft was broken for about 18 inches from the hub.The device was pulled out together with the whole system and the procedure was completed with another synergy device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device synergy xd mr us 4.00 x 8mm stent delivery system was returned to the complaint investigation site (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 51cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopically, there was no sign of damage, stretching or lifting of the stent struts and balloon cones were reviewed, and no issues were noted.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 8mm synergy? xd drug-eluting stent was advanced and inserted over the wire into a non-boston scientific guide.However, the shaft was broken for about 18 inches from the hub.The device was pulled out together with the whole system and the procedure was completed with another synergy device.No patient complications were 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: 22087097
• Report Number: 2124215-2025-34186
• Device Sequence Number: 20564492
• Product Code: NIQ
• UDI-Device Identifier: 08714729981107
• UDI-Public: (01)08714729981107(17)260619(10)34312052
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: 06/19/2026
• Device Model Number: H7493941808400
• Device Catalogue Number: H7493941808400
• Device Lot Number: 0034312052
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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 Age: 83 YR
• Patient Sex: Unknown