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

Lot Number	0032374111
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420); Difficult to Remove (1528)
Health Effect - Clinical Codes	Chest Pain (1776); Foreign Body In Patient (2687); Reduced Blood Flow (4598)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and removal difficulty occurred which required surgical intervention.The target lesion was located in the right coronary artery (rca).A 3.50 x 32mm synergy xd drug eluting stent was advanced for placement in the rca.Pre-dilation was not performed.The stent was deployed, and the balloon became stuck upon removal.Additional attempts to remove the balloon were unsuccessful and resulted in a shaft break, leaving the balloon portion inside the rca.As a result, the patient was sent to surgery where they attempted to remove the balloon, however, were unsuccessful.The balloon was left in the rca and the patient underwent a bypass to the rca to treat the event.There were no further complications reported as a result of this event.
Additional Manufacturer Narrative
B3: date of event: use first date of the month of aware date since event date was not provided.
Event or Problem Description
It was reported that shaft break and removal difficulty occurred which required surgical intervention.The target lesion was located in the right coronary artery (rca).A 3.50 x 32mm synergy xd drug eluting stent was advanced for placement in the rca.Pre-dilation was not performed.The stent was deployed, and the balloon became stuck upon removal.Additional attempts to remove the balloon were unsuccessful and resulted in a shaft break, leaving the balloon portion inside the rca.As a result, the patient was sent to surgery where they attempted to remove the balloon, however, were unsuccessful.The balloon was left in the rca and the patient underwent a bypass to the rca to treat the event.There were no further complications reported as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 32mm stent delivery system (sds) was returned for analysis: visual / tactile inspection that a visual and tactile examination of the hypotube shaft identified a break at 14cm distal to the distal end of the strain relief.A second break was noted at the guidewire exchange port with the proximal section not returned for product analysis.Multiple hypotube kinks were also noted.A break was noted at the guidewire exchange port with the distal section including the distal extrusion, balloon, tip and stent not returned for product analysis.Evidence of stretching at the guidewire exchange port was also noted.B3: date of event: use first date of the month of aware date since event date was not provided.
Event or Problem Description
It was reported that shaft break and removal difficulty occurred which required surgical intervention.The target lesion was located in the right coronary artery (rca).A 3.50 x 32mm synergy xd drug eluting stent was advanced for placement in the rca.Pre-dilation was not performed.The stent was deployed, and the balloon became stuck upon removal.Additional attempts to remove the balloon were unsuccessful and resulted in a shaft break, leaving the balloon portion inside the rca.As a result, the patient was sent to surgery where they attempted to remove the balloon, however, were unsuccessful.The balloon was left in the rca and the patient underwent a bypass to the rca to treat the event.There were no further complications reported as a result of this event.It was further reported that the target lesion, located in the rca, showed 90% focal eccentric stenosis proximally.The stent was under expanded causing the balloon tip to be wedged in the stent.Timi 1 flow was seen beyond the edge of the balloon and the patient experienced chest pain.Morphine was given.The patient was admitted to the hospital.
Additional Manufacturer Narrative
Correction: h6 patient codes, 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 returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Examination of the hypotube shaft identified a break at 14cm distal to the distal end of the strain relief.A second break was noted at the guidewire exchange port with the proximal section not returned for product analysis.Multiple hypotube kinks were also noted.A second break was noted at the guidewire exchange port with the distal section including the distal extrusion, balloon, tip and stent not returned for product analysis.Evidence of stretching at the guidewire exchange port was also noted.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 product investigation is assigned the most probable cause classification of adverse event related to procedure.This code was selected as the most probable complaint cause based on the information available and the condition of the returned device.Based on the available information and analysis of the returned device it is likely that procedural factors such as interactions with other devices and challenging anatomy would contribute to alleged complaints.It is likely the polymer extrusion was weakened as a result of excessive force (unintended) being applied to the device when attempting to removing the device which subsequently separated leaving the distal portion of the device inside the patient.The unreported hypotube kink noted during analysis most likely occurred as a result of an unintentional use error but the stage of procedure at which they occurred (during procedure/handling post procedure) cannot be established.The additional device, medication required, hospitalization, chest pain and reduced blood flow experienced by the patient were likely a result of the procedural challenges.B3: date of event: use first date of the month of aware date since event date was not 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: 19436574
• Report Number: 2124215-2024-32533
• Device Sequence Number: 8278164
• Product Code: NIQ
• UDI-Device Identifier: 08714729981084
• UDI-Public: 08714729981084
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup,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: 08/21/2025
• Device Lot Number: 0032374111
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 07/05/2024; 03/13/2026
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 07/09/2024; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown