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

Lot Number	0029974379
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the moderately tortuous and severely calcified obtuse marginal coronary artery.A 2.50 x 28mm synergy xd drug-eluting stent would not cross the lesion.Upon removal of the device, the stent fell off of the balloon in the left main/proximal circumflex artery.The detached stent was left inside the patient and an additional stent was implanted to cover the dislodged stent.The procedure was completed without any patient complications reported.The patient status was stable following the procedure.
Additional Manufacturer Narrative
Correction: h6 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 (b)(4), 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.Based on the available information, there was no evidence of device off-label use, or failure to follow the instructions for use (ifu).Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation.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 a most probable investigation conclusion code of adverse event related to patient condition.This code was selected as the most probable complaint cause based on the information available.Due to the nature of the complaint, it is not possible to test the device, under laboratory conditions, for the device's ability to track through patient anatomy.However, based on the event description the inability to cross the lesion was likely caused by the patient challenging lesion anatomy.The lesion was located in the moderately tortuous and severely calcified.The reported stent dislodgement could not be confirmed without analysis of the device.The hospitalization required and requirement for additional devices was due to the patient's condition.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the moderately tortuous and severely calcified obtuse marginal coronary artery.A 2.50 x 28mm synergy xd drug-eluting stent would not cross the lesion.Upon removal of the device, the stent fell off of the balloon in the left main/proximal circumflex artery.The detached stent was left inside the patient and an additional stent was implanted to cover the dislodged stent.The procedure was completed without any patient complications reported.The patient status was stable following 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: 20092272
• Report Number: 2124215-2024-53784
• Device Sequence Number: 7663514
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: 08714729980834
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/08/2026

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
• Device Expiration Date: 08/10/2024
• Device Lot Number: 0029974379
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 08/11/2022
• 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