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

Model Number	H7493941848300
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation issues, removal difficulty and device detachment occurred resulting in surgery.The 95% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 3.00 x 48mm synergy xd drug-eluting stent was deployed.However, the balloon only partially deflated and retracted halfway into the catheter, while its distal portion remained inflated.With the balloon still left in the stent, it was unable to be completely removed.The patient turned very ischemic while the balloon remained inflated.Despite multiple attempts to go up and down on the stent balloon, the encore 26 inflation device was unable to achieve full deflation.An attempt to use a double-wire technique was made to deflate the affected portion of the balloon.The distal tip of the stent catheter was then cut, and a guide extension was placed over the catheter; but the extension could not be advanced outside the guide catheter.Additionally, the physician held retraction on the stent catheter and wire, when the catheter fractured distally.Following an attempt to pull the wire and the entire complex out, the wire came back, and position was lost.Without a guidewire in place, a snare was then used to try to retrieve the balloon.Balloon fragment removal was attempted for an hour and half before sending the patient to surgery.The patient was taken for bypass surgery, during which the balloon and cut distal tip of the stent catheter were successfully removed.Upon retrieval, it was noted that the distal portion of the balloon remained inflated.At the time of reporting, the patient was stable, remained under monitoring, and had not yet been discharged following the surgery.No further issues were reported.

• 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: 22325419
• Report Number: 2124215-2025-39770
• Device Sequence Number: 15700257
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: (01)08714729985228
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 06/25/2025

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: H7493941848300
• Device Catalogue Number: H7493941848300
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/25/2025
• 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
• Patient Sex: Unknown