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

Model Number	H7493941820400
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation issue occurred.A 4.00 x 20mm synergy xd drug-eluting stent was deployed.However, during the procedure, the balloon failed to fully deflate, and it would not go back into guide catheter.Multiple deflation attempts were made, but the balloon did not completely down.The physician then removed the guide catheter, balloon and the non-boston scientific guidewire.The procedure was completed with a different device, and 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 4.00 x 20mm was returned within a guide catheter which could be removed without resistance.A visual and tactile examination identified a break on the hypotube shaft, 26cm distal to the distal end of the strain relief with multiple kinks present.A microscopic examination identified the balloon cones were subjected to positive pressure and returned in a deflated state.When returned, the proximal section of the balloon profile was submerged within the guide catheter.Bumper tip showed no signs of distal tip damage.The inner lumen was bunched and prolapsed, 6.7cm from the distal tip.There was no damage noted on the outer lumen.Functional testing was conducted.The device was attached to an inflation aid where an attempt was made to inflate and then deflate the balloon however the liquid was seen coming from the distal tip due to the prolapsed inner lumen noted 6.7cm from the tip.
Event or Problem Description
It was reported that deflation issue occurred.A 4.00 x 20mm synergy xd drug-eluting stent was deployed.However, during the procedure, the balloon failed to fully deflate, and it would not go back into guide catheter.Multiple deflation attempts were made, but the balloon did not completely down.The physician then removed the guide catheter, balloon and the non-boston scientific guidewire.The procedure was completed with a different device, and there were no patient complications reported.It was further reported that the target lesion was located in the ostial right coronary artery and was 95% stenosed, non-tortuous, and mildly calcified.Balloon angioplasty was performed using the encore 26 inflation device, with a saline-contrast ratio of 40/50.The balloon was inflated at 18 atmospheres for 15 seconds with no symptoms.The balloon was removed intact in a partially deflated state.

• 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: 22974961
• Report Number: 2124215-2025-59283
• Device Sequence Number: 15795305
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: (01)08714729981138(17)260909(10)34859553
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 10/15/2025

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: 09/09/2026
• Device Model Number: H7493941820400
• Device Catalogue Number: H7493941820400
• Device Lot Number: 0034859553
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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