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

Model Number	H7493941816300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used the first day of the aware date month as the event date as it was unknown.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 device detachment occurred.The target lesion was located in the proximal left anterior descending artery.A 3.00 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, part of the device detachment occurred.There were no patient complications reported.No further information provided.
Additional Manufacturer Narrative
B3: date of event: used the first day of the aware date month as the event date as it was unknown.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.The returned device consisted of the synergy xd stent delivery system.A visual inspection showed a break in the midshaft, 21.6cm from the distal tip.The cause of the device detachment could not be determined however based on review of manufacturing records there is no evidence that a manufacturing issue caused or contributed to the event and similar complaints have been reported for this batch.No patient details or procedural media were received therefore a definitive conclusion cannot be determined.
Event or Problem Description
It was reported that device detachment occurred.The target lesion was located in the proximal left anterior descending artery.A 3.00 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, part of the device detachment occurred.There were no patient complications reported.No further information provided.

• 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: 22484173
• Report Number: 2124215-2025-41337
• Device Sequence Number: 8668769
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: (01)08714729980964(17)260109(10)33279751
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 01/20/2026

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: 01/09/2026
• Device Model Number: H7493941816300
• Device Catalogue Number: H7493941816300
• Device Lot Number: 0033279751
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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