MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY? XD; coronary drug-eluting stent

Model Number	H7493941838250
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Material Rupture (1546); Activation Failure (3270); Failure to Deflate (4060)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that multiple device issue occurred requiring additional intervention.The target lesion was located in a non-tortuous vessel.The 2.50 x 38 mm synergy xd drug eluting stent was selected for use.The technician noted resistance upon removing the balloon protector and stylet from the stent delivery system (sds) and informed the physician.The physician did not notice any visible damage to the sds balloon and decided to use the device.Upon advancing the stent to the lesion, the physician got the stent in the correct position and told the scrub technician to inflate/deploy the stent.During the attempt to deploy the stent at 12 atm, the inflation device kept spinning as if it was being inflated, but the balloon never completely inflated, and the stent seemed to only partially deploy around 2 atm.Upon trying to remove the device, the balloon appeared to not have deflated properly and became stuck.Another physician was consulted and the decision was made to remove everything as a whole, the guide catheter, guidewire, and sds.When the system was pulled, the balloon snagged and caused the stent to fracture into two pieces.The sds was removed as a whole, but the fractured stent remained.Upon removal of the sds, there appeared to be a tear in the distal end of the balloon.An attempt was made to re-wire through the fractured stent pieces for removal, without success.One part of the stent migrated to the distal portion of the saphenous vein graft (svg) to second obtuse marginal (om2) and the other portion stayed in the ostial/proximal portion of the svg to om2.A 3.5mm x 48mm synergy xd was used to crush the ostial/proximal stent fragment, and a 3.5mm x 32mm synergy xd was used to crush and cover the distal stent fragment.No patient complications were reported, and the patient outcome was stable.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50893170
• Report Number: 2124215-2026-51098
• Device Sequence Number: 5829275
• Product Code: NIQ
• UDI-Device Identifier: 08714729980858
• UDI-Public: (01)08714729980858(17)280127(10)38539705
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: H7493941838250
• Device Catalogue Number: H7493941838250
• Device Lot Number: 0038539705
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 01/27/2026
• 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 Sex: Unknown