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

Model Number	H7493941832450
Medical Device Problem Codes	Break (1069); Failure to Deflate (4060)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Foreign Body In Patient (2687)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that deflation failure and shaft break occurred resulting in cardiac arrest, additional intervention and an unretrieved device fragment.The target lesion was located in the circumflex artery.A stent was initially placed in the circumflex artery, followed by a 4.50 x 32mm synergy xd drug-eluting stent placed in the circumflex artery extending to the left main ostium.After deployment, the balloon failed to deflate.Multiple unsuccessful attempts were made to deflate the balloon with the inflation device.A hornet 14 guidewire was then used to attempt to puncture the balloon.Additionally, the back end of the balloon was cut off in an attempt to release the pressure.When the physician tried to retract the balloon, the balloon shaft broke, leaving the balloon stuck in the left main/circumflex artery.The patient became unstable and experienced cardiac arrest and a minimally invasive, temporary heart pump was placed.A second physician scrubbed in and was able to advance a non-boston scientific guidewire and a microcatheter past the balloon to the distal circumflex.Then, a 2.0 balloon was advanced and was able to restore flow.The physician used progressively bigger balloons and then was able to advance a 3.5 x 20mm synergy into the circumflex artery/left main and deployed the stent.That stent was posted with a 4.0 x 20mm balloon.The remaining broken balloon from the first stent remained trapped between the two stents.Timi 3 flow was restored and the patient stabilized.The heart pump was removed; the patient was discharged from the hospital and is expected to fully recover.

• 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: 22690330
• Report Number: 2124215-2025-52550
• Device Sequence Number: 8251052
• Product Code: NIQ
• UDI-Device Identifier: 08714729981237
• UDI-Public: (01)08714729981237(17)270206(10)35855806
• 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
• Report Date (Section B): 08/01/2025

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: H7493941832450
• Device Catalogue Number: H7493941832450
• Device Lot Number: 0035855806
• 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: 07/09/2025
• Initial Report FDA Received Date: 08/01/2025
• Date Device Manufactured: 02/06/2025
• 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; Other
• Patient Sex: Unknown