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

Model Number	H7493941824300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via user medwatch (b)(4) that stent dislodgement occurred.A percutaneous intervention (pci) procedure was being performed.The 80% stenosed target lesion was located in a non-tortuous and a significant calcified coronary artery.A 3.00 x 24mm synergy? xd drug-eluting stent was advanced.However, prior to the application of any pressure, the stent came off the balloon system.The stent was jailed inside the patient using a 1.50 x 15 non-boston scientific balloon, a 2.00 x 20 emerge and 3.00 x 15 nc emerge.The procedure was completed.The patient was discharged to an skilled nursing facility and was later transitioned home with home health, physical therapy, and occupational therapy.An ejection fraction (ef) of 35% was noted, and a cardiac resynchronization therapy with defibrillator (crt-d) device was implanted post-pci.
Additional Manufacturer Narrative
A4 weight: 65.8 kg.

• 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: 25364019
• Report Number: 2124215-2026-28940
• Device Sequence Number: 10650582
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: (01)08714729980988(17)280105(10)38328125
• Combination Product (Y/N): Y
• Initial Reporter State: MT
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: H7493941824300
• Device Catalogue Number: H7493941824300
• Device Lot Number: 0038328125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 01/05/2026
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White