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

Model Number	H7493941812500
Medical Device Problem Codes	Nonstandard Device (1420); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.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 stent premature deployment occurred.The target lesion was located in a coronary artery.A 5.00 x 12mm synergy xd drug-eluting stent was selected for use.However, the stent was partially deployed and physician decided not to use it.They pulled another device and worked perfectly.
Event or Problem Description
It was reported that stent premature deployment occurred.The target lesion was located in a coronary artery.A 5.00 x 12mm synergy xd drug-eluting stent was selected for use.However, the stent was partially deployed and physician decided not to use it.They pulled another device and worked perfectly.
Additional Manufacturer Narrative
B3: date of event: used first date of the month since exact event date was not provided.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 evaluated by mfr.: synergy xd mr us 5.00 x 12mm stent delivery system (sds) was returned for analysis.Visual and tactile inspection found no issues on the hypotube shaft.Examination of the polymer extrusion noted the inner lumen was damaged.Microscopic analysis revealed no sign of damage, stretching or lifting of the stent struts and no signs of a deploying stent.Examination of the polymer extrusion noted the inner lumen was damaged (stretched and bunched) at 5.5cm from the tip of the device.Balloon material was 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.A microscopic examination of the proximal and distal markerbands identified no damage.The device was attached to a testing encore inflation unit, and the balloon was inflated and held pressure and the stent deployed without issues.The balloon inflated to rate burst pressure of 16 atmospheres and deflated without issue.The encore device was verified before and after use using the druck gauge.

• 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: 23899024
• Report Number: 2124215-2025-93225
• Device Sequence Number: 21426288
• Product Code: NIQ
• UDI-Device Identifier: 08714729981244
• UDI-Public: (01)08714729981244(17)260618(10)34370996
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 02/18/2026

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: 06/18/2026
• Device Model Number: H7493941812500
• Device Catalogue Number: H7493941812500
• Device Lot Number: 0034370996
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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