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

Model Number	H7493941812400
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The less than 30% stenosed target lesion was located in a moderately tortuous and severely calcified proximal coronary artery.A 4.00 x 12mm synergy? xd drug-eluting stent was selected for treatment.During the procedure, the physician was unable to advance the device, and upon removal, the shaft was found to be broken.The device was retrieved successfully, and the procedure was completed with a new stent.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The less than 30% stenosed target lesion was located in a moderately tortuous and severely calcified proximal coronary artery.A 4.00 x 12mm synergy? xd drug-eluting stent was selected for treatment.During the procedure, the physician was unable to advance the device, and upon removal, the shaft was found to be broken.The device was retrieved successfully, and the procedure was completed with a new stent.No patient complications were reported.
Additional Manufacturer Narrative
D4 batch lot number updated.Device evaluated by mfr: a synergy xd mr ous 4.00 x 12mm drug-eluting stent (des), was returned to the complaint investigation site (cis).A visual and tactile examination of the hypotube shaft identified a break 17.8cm distal to the distal end of the strain relief, 82cm proximal from the port exchange and a middle segment that was 21cm in length.Multiple kinks were also identified along the length of the hypotube.No kinks or damages were identified with the outer or mid-shaft sections of the inner lumen of the device.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.A microscopic examination of the distal and proximal markerbands identified no damage.The distal bumper tip showed was flared.No other device issues were identified during returned product analysis.

• 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: 23546896
• Report Number: 2124215-2025-82721
• Device Sequence Number: 9609575
• Product Code: NIQ
• UDI-Device Identifier: 08714729981114
• UDI-Public: (01)08714729981114(17)260910(10)34873274
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2026
• Device Model Number: H7493941812400
• Device Catalogue Number: H7493941812400
• Device Lot Number: 0034873274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male