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

Model Number	H7493941820250
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred, resulting in an additional intervention.The patient presented with coronary artery disease.The target lesion was an area of in-stent restenosis (isr) located in the moderately tortuous and calcified left anterior descending (lad) artery.After ballooning the old stent with isr multiple times, the physician attempted to deliver and deploy a 2.50 x 20 mm synergy? xd drug-eluting stent (des) distally to cover a dissection.A non-boston scientific (bsc) wire, a 6f non-bsc guide extension catheter, and a non-bsc guide wire were in place when the stent became dislodged in the proximal lad, proximal to the previously implanted stent.A 1.00 x 10 mm balloon catheter was inserted in an attempt to recapture the dislodged stent into the guide catheter by inflating the balloon distal to the stent and pulling back.However, this maneuver was unsuccessful.As the stent could not be retrieved, it was ultimately deployed in place, and multiple balloons were used to dilate the stent up to 3.50 mm.The procedure was completed successfully, and no patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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: 23408025
• Report Number: 2124215-2025-76048
• Device Sequence Number: 12963606
• Product Code: NIQ
• UDI-Device Identifier: 08714729980810
• UDI-Public: (01)08714729980810(17)261105(10)35315238
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493941820250
• Device Catalogue Number: H7493941820250
• Device Lot Number: 0035315238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/28/2025
• Date Device Manufactured: 11/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown