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

Model Number	H7493941816300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00 x 16mm synergy xd drug-eluting stent was selected for treatment.However, the stent was found to be damaged upon removal from the package and the stent struts had separated from the balloon.The procedure was completed with a different device, and no patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.00 x 16mm synergy xd drug-eluting stent was selected for treatment.However, the stent was found to be damaged upon removal from the package and the stent struts had separated from the balloon.The procedure was completed with a different device, and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd 3.00 x 16mm was returned for analysis.A visual inspection of the hypotube shaft noted multiple kinks.A visual and tactile examination of the crimped stent via scope found evidence of stent damage with stent struts lifted at the mid-section and pulled distally over the balloon cone and tip.A dimensional testing of the undamaged crimped stent od (outer diameter) was measured by snap gauge and the result was (b)(4) within max crimped stent profile measurement.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A microscopic examination of the 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.The unreported hypotube kinks noted during analysis most likely occurred as a result of an unintentional user error but the stage of procedure at which they occurred (during procedure/handling post procedure) cannot be established.

• 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: 21785403
• Report Number: 2124215-2025-19917
• Device Sequence Number: 15622203
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: (01)08714729980964(17)260904(10)34877118
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 09/04/2026
• Device Model Number: H7493941816300
• Device Catalogue Number: H7493941816300
• Device Lot Number: 0034877118
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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