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

Model Number	H7493941816250
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left circumflex coronary artery (lcx) which contained a 90-degree bend.A 2.50mm x 16mm synergy xd drug eluting stent was selected for use.During the procedure, resistance was encountered when the stent was being advanced through a non-boston scientific (non-bsc) guide catheter with two non-bsc guidewires and a guidezilla guide extension catheter.When the stent was pulled back for repositioning, the stent was dislodged from the stent delivery system (sds) balloon, and the non-bsc wires broke off at the radiopaque portions.The dislodged stent was crushed at the ostial/proximal lcx, and another stent was able to cross and be delivered at the ostial/proximal segment.There were no complications reported, and the patient was stable after the procedure.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review if completed: a risk review was performed, and it confirmed that the event of dislodged inside the patient and difficult to advance was defined in the risk documentation and is recorded accordingly in the product record review.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned an investigation conclusion code of adverse event related to procedure.This code was selected as the most probable complaint cause based on the information available.Based on the event details, it is most likely that the difficulty to advance and stent dislodgement occurred due to procedural factors.This complex coronary procedure involved an anatomy with a 90-degree bend where two guidewires were used in addition to a guide catheter extension.The physician reported tension and resistance while advancing the stent into the coronary through the guide catheter with the wires and guide catheter extension.While attempting to pull back for repositioning the stent became dislodged from the balloon.It is most likely that this pull back action into the guide catheter caused the stent to strip off the balloon.The ifu notes caution to be taken when moving an unexpanded stent in and out through the distal end of the guide catheter in case of dislodgement.Tension and resistance is most likely due to using multiple devices through the guide catheter.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left circumflex coronary artery (lcx) which contained a 90-degree bend.A 2.50mm x 16mm synergy xd drug eluting stent was selected for use.During the procedure, resistance was encountered when the stent was being advanced through a non-boston scientific (non-bsc) guide catheter with two non-bsc guidewires and a guidezilla guide extension catheter.When the stent was pulled back for repositioning, the stent was dislodged from the stent delivery system (sds) balloon, and the non-bsc wires broke off at the radiopaque portions.The dislodged stent was crushed at the ostial/proximal lcx, and another stent was able to cross and be delivered at the ostial/proximal segment.There were no complications reported, and the patient was stable after the procedure.

• 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: 21305844
• Report Number: 2124215-2025-04444
• Device Sequence Number: 8244179
• Product Code: NIQ
• UDI-Device Identifier: 08714729980803
• UDI-Public: 08714729980803
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 04/27/2026

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: 08/12/2026
• Device Model Number: H7493941816250
• Device Catalogue Number: H7493941816250
• Device Lot Number: 0034658635
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 08/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER-GUIDE EXTENSION - GUIDEZILLA; CATHETER-GUIDE EXTENSION - GUIDEZILLA; GUIDE CATHETER - 8F EBU; GUIDE CATHETER - 8F EBU; GUIDEWIRE - ASAHI GRAND SLAM WIRES; GUIDEWIRE - ASAHI GRAND SLAM WIRES
• Patient Sex: Unknown