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

Model Number	H7493941838300
Medical Device Problem Codes	Inflation Problem (1310); Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon would not inflate, and the sleeve of the device was inadvertently left in the patient and had to be surgically removed.The patient was referred for a vascular procedure post mitral valve area (mva) for vascular arterial thrombus.A flap dissection was found in the tibioperoneal (tp) trunk.During the initial procedure on (b)(6) 2024, a 3.00 x 38mm synergy xd drug-eluting stent was advanced for treatment, however the balloon would not inflate.The device was removed, and a different stent was deployed without issue.However, the patient was brought back to the operating room (or) for thrombus formation and exploratory surgery.A.Surgery revealed a foreign body of a piece of plastic cover present on all coronary stents and balloons along with the a stylet, found in the popliteal artery.It is believed that the plastic cover/sleeve was left in the body during withdrawal of the stent delivery system.No fragments were left inside the patient after the surgery, and the patient was 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: 21401020
• Report Number: 2124215-2025-07152
• Device Sequence Number: 13155764
• Product Code: NIQ
• UDI-Device Identifier: 08714729981015
• UDI-Public: 08714729981015
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/18/2025

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: H7493941838300
• Device Catalogue Number: H7493941838300
• 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: 01/22/2025
• Initial Report FDA Received Date: 02/18/2025
• 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