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

Model Number	H7493941832400
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that shaft break occurred.4.00 x 32mm synergy? xd drug-eluting stent was advanced for treatment.However, during advancing, the stent shaft was broken.Subsequently, another 4.00 x 32mm synergy? xd stent was advanced, and the shaft was also broken.Both devices were pulled and removed from the patient.The procedure was completed with a different device successfully with no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 32mm synergy? xd drug-eluting stent was advanced for treatment.However, during advancing, the stent shaft was broken.Subsequently, another 4.00 x 32mm synergy? xd stent was advanced, and the shaft was also broken.Both devices were pulled and removed from the patient.The procedure was completed with a different device successfully with no patient complications reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the 4.00 x 32mm synergy xd stent delivery system was returned for analysis.A visual and tactile examination of the hypotube found multiple kinks along the shaft and a break at 98cm from port exchange with manifold detached and not returned.A visual and tactile examination identified multiple polymer extrusion kinks.Microscopic examination of the crimped stent via scope found evidence of stent damage with stent struts lifted in mid-section.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review (prr) table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned a most probable investigation conclusion code of cause not established.This code was selected as the most probable complaint cause based on the condition of the returned device.Analysis of the returned device confirmed a break in the hypotube.One possibility that a break occurred during advancement through the guide catheter due to excessive force applied to the delivery system, combined with interactions with other ancillary devices used during the procedure, which led to its separation.The unreported kinks noted during device analysis occurred most likely due to post-procedure handling when repackaging the device for return and the unreported stent damage most likely occurred during interactions of the device with the lesion's anatomical features, as well as interactions with other ancillary devices used during the 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 ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23860452
• Report Number: 2124215-2025-92206
• Device Sequence Number: 21245341
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: (01)08714729981169(17)261001(10)35089781
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 10/01/2026
• Device Model Number: H7493941832400
• Device Catalogue Number: H7493941832400
• Device Lot Number: 0035089781
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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 Sex: Unknown