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

Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Arrhythmia (1721); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	10/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred resulting in vessel occlusion.The patient presented with a non-st-elevation myocardial infarction (nstemi).A 3.50 x 20 mm synergy xd drug-eluting stent was to be deployed in the proximal circumflex.During the procedure, the patient went into ventricular fibrillation (vfib) and was brought back to sinus rhythm while the balloon was deflated.Upon returning to fluoroscopy, the physician could still see the marker bands of the balloon.However, the balloon came off the shaft when it was pulled out.The physician then was unable to snare it or cross another device, which caused the vessel to occlude.The circumflex shut down, resulting in no flow.The patient has been intubated and is in the intensive care unit (icu).No further issues were reported.
Additional Manufacturer Narrative
B5.Describe event or problem updated.H6.Patient, impact and device code updated.
Event or Problem Description
It was reported that stent dislodgement occurred resulting in vessel occlusion.The patient presented with a non-st-elevation myocardial infarction (nstemi).A 3.50 x 20 mm synergy xd drug-eluting stent was to be deployed in the proximal circumflex.During the procedure, the patient went into ventricular fibrillation (vfib) and was brought back to sinus rhythm while the balloon was deflated.Upon returning to fluoroscopy, the physician could still see the marker bands of the balloon.However, the balloon came off the shaft when it was pulled out.The physician then was unable to snare it or cross another device, which caused the vessel to occlude.The circumflex shut down, resulting in no flow.The patient has been intubated and is in the intensive care unit (icu).No further issues were reported.It was further reported that the stent was not detached as what was previously reported, rather it was a shaft break that left the balloon section behind.
Additional Manufacturer Narrative
Correction: h6 patient codes and impact codes.This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Device analysis results: device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are 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.There is no evidence that the device was used in a manner inconsistent with the labelled indications.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned the most probable cause classification of cause not established.This code was selected as the most probable complaint cause based on the information available.Based on the event description it is likely that a break occurred in the shaft (near the location of the balloon) and this detached section of device, which contained the balloon and markerbands, was attempted to be snared out of the patient with no success.The exact cause of the break is unknown.One possibility is that the physician did not allow or have enough time for the balloon to fully deflate, after the patient went into ventricular fibrillation (vfib).It is noted per the products instructions for use that the user is instructed to allow a minimum time of 30 seconds for the balloon to fully deflate.The complaint reported that to their best recollection the balloon was deflated.If the balloon was not fully deflated then this would likely result in a restriction occurring during the attempts to remove the device, which likely resulted in the shaft break.
Event or Problem Description
It was reported that stent dislodgement occurred resulting in vessel occlusion.The patient presented with a non-st-elevation myocardial infarction (nstemi).A 3.50 x 20 mm synergy xd drug-eluting stent was to be deployed in the proximal circumflex.During the procedure, the patient went into ventricular fibrillation (vfib) and was brought back to sinus rhythm while the balloon was deflated.Upon returning to fluoroscopy, the physician could still see the marker bands of the balloon.However, the balloon came off the shaft when it was pulled out.The physician then was unable to snare it or cross another device, which caused the vessel to occlude.The circumflex shut down, resulting in no flow.The patient has been intubated and is in the intensive care unit (icu).No further issues were reported.It was further reported that the stent was not detached as what was previously reported, rather it was a shaft break that left the balloon section behind.

• 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: 20545256
• Report Number: 2124215-2024-67302
• Device Sequence Number: 18099812
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/07/2026

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
• 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: 10/06/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 03/13/2026
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/26/2024; 04/07/2026
• 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