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

Model Number	H7493941848400
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified coronary artery.Pre-dilatation was performed with a 4.0mm emerge balloon catheter.A 4.00x48mm synergy xd drug-eluting stent (des) was selected for treatment, but it would not advance through the guide extension catheter.When the stent was pulled out, it became stretched over the end of the distal portion of the balloon and was dislodged from the delivery system.Subsequently, another 4.00x48mm synergy xd des was selected for treatment, but the balloon and stent became malformed, and the stent was again dislodged from the delivery system.The procedure was then completed with a different device, and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 4.00 x 48mm was returned for analysis.A visual and tactile inspection revealed no issues identified with 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 of the stent identified struts pulled from the distal section over the distal tip.The bumper tip showed no signs of distal tip damage.Dimensional testing included measurement of the undamaged crimped stent od (outer diameter) and the result was within max crimped stent profile measurement.A device-to-device interaction test identified the device could not fit through a guide catheter due to the damaged stent struts.
Event or Problem Description
It was reported that stent dislodgement occurred.The 60% stenosed target lesion was located in the mildly tortuous and moderately calcified coronary artery.Pre-dilatation was performed with a 4.0mm emerge balloon catheter.A 4.00x48mm synergy xd drug-eluting stent (des) was selected for treatment, but it would not advance through the guide extension catheter.When the stent was pulled out, it became stretched over the end of the distal portion of the balloon and was dislodged from the delivery system.Subsequently, another 4.00x48mm synergy xd des was selected for treatment, but the balloon and stent became malformed, and the stent was again dislodged from the delivery system.The procedure was then completed with a different device, and no patient complications were reported.

• 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: 21287355
• Report Number: 2124215-2025-01667
• Device Sequence Number: 7831107
• Product Code: NIQ
• UDI-Device Identifier: 08714729985242
• UDI-Public: (01)08714729985242(17)251023(10)32789498
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 04/24/2025

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: 10/23/2025
• Device Model Number: H7493941848400
• Device Catalogue Number: H7493941848400
• Device Lot Number: 0032789498
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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 Sex: Unknown