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

Model Number	H7493941812220
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	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with a coronary artery disease and underwent coronary intervention.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The physician stated that the lesion was very difficult to prepare.A 2.25 x 32 mm synergy xd drug-eluting stent (des) was advanced for treatment; however, it was noted that the stent felt as though it was getting hung up in the 6f guidezilla guide extension catheter, and the stent was unable to be advanced.All access was lost as the stent, the guidezilla, and the guidewire all came out together.A new 2.25 x 12m synergy xd des was used; but the stent was also difficult to advance and ended up breaking in the guide.Both stents were removed and no foreign material remained in the patient.The lesion was further prepped, and another stent was deployed to complete the procedure.There were no patient complications and the patient fully recovered.
Additional Manufacturer Narrative
Investigation results: device analysis findings: synergy xd mr us 2.25 x 12mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination identified a hypotube break 19.7cm distal to the distal end of the strain relief and multiple hypotube kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A microscopic examination identified no sign of damage, stretching or lifting of the stent struts.Balloon cones were reviewed under microscopic examination, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A microscopic examination of the bumper tip showed no signs of distal tip damage.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.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 table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of adverse event related to patient condition.This conclusion code is based on the available information, reported anatomical characteristics and the review conducted at the boston scientific site.This was the second device used during the procedure which experienced advancement difficulty within the guide and guide catheter extension.Returned product analysis confirmed the damage with a hypotube break and identified multiple hypotube kinks.Based on the available information it was initially stated that the lesion was very difficult to prepare, it is likely that the difficulty in advancing experienced with multiple devices and observed damage was due to interaction between this device, ancillary devices and the lesion conditions present in the vessel being treated (90% stenosis, moderate calcification and moderate tortuosity).
Event or Problem Description
It was reported that shaft break occurred.The patient presented with a coronary artery disease and underwent coronary intervention.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The physician stated that the lesion was very difficult to prepare.A 2.25 x 32 mm synergy xd drug-eluting stent (des) was advanced for treatment; however, it was noted that the stent felt as though it was getting hung up in the 6f guidezilla guide extension catheter, and the stent was unable to be advanced.All access was lost as the stent, the guidezilla, and the guidewire all came out together.A new 2.25 x 12m synergy xd des was used; but the stent was also difficult to advance and ended up breaking in the guide.Both stents were removed and no foreign material remained in the patient.The lesion was further prepped, and another stent was deployed to complete the procedure.There were no patient complications and the patient fully recovered.

• 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: 24496019
• Report Number: 2124215-2026-11603
• Device Sequence Number: 10616916
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: (01)08714729980711(17)260923(10)35002060
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 04/07/2026

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: 09/23/2026
• Device Model Number: H7493941812220
• Device Catalogue Number: H7493941812220
• Device Lot Number: 0035002060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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