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

Model Number	H7493941838400
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 38mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube shaft identified no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section identified no issues.The stent was not returned for product analysis.Balloon material was reviewed.Microscopic examination of the balloon identified a longitudinal tear, 7mm in length across the mid-section of balloon body.Bumper tip showed no signs of distal tip damage.A leakage test could not be performed due to the longitudinal tear in the balloon body.
Event or Problem Description
Reportable based on device analysis completed on 25-aug-2025.It was reported that balloon leak was encountered.The 70% stenosed target lesion was located in a mildly tortuous and mildly calcified coronary artery.A 4.00 x 38mm synergy xd drug-eluting stent was advanced for treatment.However, the balloon was inflated to 8 atmospheres before deflating immediately.The stent was opposed to the vessel wall enough to remove the balloon.The stent was post dilated with a non-compliant (nc) balloon and patient was fine.The procedure was completed using an alternate device.However, returned device analysis revealed balloon torn.

• 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: 23057715
• Report Number: 2124215-2025-63433
• Device Sequence Number: 9226161
• Product Code: NIQ
• UDI-Device Identifier: 08714729981176
• UDI-Public: (01)08714729981176(17)260722(10)34542718
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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: 07/22/2026
• Device Model Number: H7493941838400
• Device Catalogue Number: H7493941838400
• Device Lot Number: 0034542718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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