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

Model Number	H7493941848300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent fracture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified left main (lm) and left anterior descending (lad) artery.The physician performed rotational atherectomy of the lm and lad using a 1.5 mm burr.Following nc balloon dilation, high-definition intravascular ultrasound (ivus) imaging was performed.After ivus assessment, a 3.5 non-boston scientific intravascular lithotripsy (ivl) balloon was used for further lesion preparation.A 3.00 x 48mm synergy? xd drug-eluting stent (des) was advanced using a guidezilla extension catheter and deployed in the target segment.Post deployment, the stent has fractured approximately 20- 25 mm back from distal tip of the stent as confirmed through ivus imaging.The physician performed post-dilation with a 3.0 nc balloon.The fractured stent was covered with a 3.0 x 16mm synergy des, and the procedure was completed.No complications were reported, and the patient remained stable post procedure.

• 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: 50229880
• Report Number: 2124215-2026-43367
• Device Sequence Number: 10256692
• Product Code: NIQ
• UDI-Device Identifier: 08714729985228
• UDI-Public: (01)08714729985228(17)280329(10)39050610
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 09/23/2026

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: H7493941848300
• Device Catalogue Number: H7493941848300
• Device Lot Number: 0039050610
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 03/30/2026
• 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: 77 YR
• Patient Sex: Male