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

Model Number	H7493941832350
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in coronary artery.A 3.50 x 32 mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion, the shaft broke in half.The device was removed, and the procedure was completed with another 3.5 x 32 synergy xd stent.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in coronary artery.A 3.50 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion, the shaft broke in half.The device was removed, and the procedure was completed with another 3.5x32 synergy xd stent.No patient complications were reported.It was further reported that the target lesion was located in the moderately tortuous and severely calcified right coronary artery with 85-90% stenosis.The device was completely removed by pulling it manually and came out with the wire.
Additional Manufacturer Narrative
Device evaluated by mfr; synergy xd mr us 3.50 x 32mm stent delivery system was returned for analysis.A visual and tactile examination of the hypotube shaft identified multiple hypotube kinks and a break at 23cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis revealed that there was no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed, and no issues were noted.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in coronary artery.A 3.50 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion, the shaft broke in half.The device was removed, and the procedure was completed with another 3.5x32 synergy xd stent.No patient complications were reported.It was further reported that the target lesion was located in the moderately tortuous and severely calcified right coronary artery with 85-90% stenosis.The device was completely removed by pulling it manually and came out with the wire.

• 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: 21926758
• Report Number: 2124215-2025-27175
• Device Sequence Number: 9031458
• Product Code: NIQ
• UDI-Device Identifier: 08714729981084
• UDI-Public: (01)08714729981084(17)250516(10)31807802
• 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
• 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,Followup
• Report Date (Section B): 08/12/2025

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: 05/16/2025
• Device Model Number: H7493941832350
• Device Catalogue Number: H7493941832350
• Device Lot Number: 0031807802
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/02/2025; 07/24/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/04/2025; 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White