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

Model Number	H7493941848250
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported failure to deflate, difficult to remove, and shaft break occurred requiring additional intervention.The target lesion was located in the mid circumflex artery, extending toward the second obtuse marginal (om) branch.A 2.50 x 48 mm synergy xd drug-eluting stent was deployed at the intended lesion site using a 6fr guide catheter.The stent was inflated to 11 atmospheres and held for 15 seconds.Following deployment, the balloon failed to deflate properly.The physician waited for balloon deflation before attempting device withdrawal.Upon withdrawal, the balloon became stuck on the deployed stent.When additional traction was applied, the delivery system shaft broke.The broken portion of the shaft was retrieved using a snare device.The procedure was completed successfully; however, the patient expired prior to hospital discharge due to a pulmonary embolism (pe) arrest.

• 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: 22722796
• Report Number: 2124215-2025-50403
• Device Sequence Number: 21248751
• Product Code: NIQ
• UDI-Device Identifier: 08714729985204
• UDI-Public: (01)08714729985204(17)261126(10)35447551
• 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
• 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
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493941848250
• Device Catalogue Number: H7493941848250
• Device Lot Number: 0035447551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 11/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown