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

Model Number	H7493941832500
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent moved on the balloon.The patient underwent percutaneous coronary intervention (pci).A 5.00 x 32mm synergy xd drug-eluting stent (des) was selected for treatment.During insertion, the stent failed to advance in the 6fr non-boston scientific guide catheter, and it was noted that the stent unraveled from the catheter.The stent did remain on the balloon with no issues to the patient.A non-bsc stent was successfully deployed to treat the lesion and complete the procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 5.00 x 32mm was returned for analysis.A visual and tactile examination identified multiple 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.The stent was pulled from the proximal section and stretched over the distal tip.Balloon cones were reviewed under microscopic examination, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The device could not track through a test guide catheter due to the extent of the stent damage.
Event or Problem Description
It was reported that the stent moved on the balloon.The patient underwent percutaneous coronary intervention (pci).A 5.00 x 32mm synergy xd drug-eluting stent (des) was selected for treatment.During insertion, the stent failed to advance in the 6fr non-boston scientific guide catheter, and it was noted that the stent unraveled from the catheter.The stent did remain on the balloon with no issues to the patient.A non-bsc stent was successfully deployed to treat the lesion and complete the procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 5.00 x 32mm was returned for analysis.A visual and tactile examination identified multiple 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.The stent was pulled from the proximal section and stretched over the distal tip.Balloon cones were reviewed under microscopic examination, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The device could not track through a test guide catheter due to the extent of the stent damage.
Event or Problem Description
It was reported that the stent moved on the balloon.The patient underwent percutaneous coronary intervention (pci).A 5.00 x 32mm synergy xd drug-eluting stent (des) was selected for treatment.During insertion, the stent failed to advance in the 6fr non-boston scientific guide catheter, and it was noted that the stent unraveled from the catheter.The stent did remain on the balloon with no issues to the patient.A non-bsc stent was successfully deployed to treat the lesion and complete the procedure.No patient complications were reported as a result of this event.

• 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: 22929213
• Report Number: 2124215-2025-59281
• Device Sequence Number: 13040717
• Product Code: NIQ
• UDI-Device Identifier: 08714729981299
• UDI-Public: (01)08714729981299(17)260716(10)34589445
• 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,Followup
• Report Date (Section B): 12/18/2025

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: 07/16/2026
• Device Model Number: H7493941832500
• Device Catalogue Number: H7493941832500
• Device Lot Number: 0034589445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/10/2025; 11/24/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/02/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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