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

Model Number	H7493941828250
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Codes	Anemia (1706); Cardiac Arrest (1762); Ventilator Dependent (2395); Foreign Body In Patient (2687)
Date of Event	01/06/2026
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported via medwatch mw5182566 that the patient died.The patient presented with coronary artery disease with unstable angina admitted for elective left heart catheterization.A 2.50 x 28mm synergy? xd drug-eluting stent was advanced for treatment using a non-boston scientific (non-bsc) guide extension catheter.However, during the inflation at six atmospheres the stent delivery system balloon ruptured.The stent and balloon could not be withdrawn through an older proximal stent.The proximal portion of the balloon was retracted out of the newly under-deployed stent.Multiple attempts were made to retrieve the retained equipment using wire escalation and a microcatheter.The patient subsequently experienced cardiac arrest, after which a non-bsc heart pump and temporary pacing wire were placed.The physician made several unsuccessful snare attempts to retrieve the retained balloon fragment from the ascending aorta.The patient was then admitted to the icu.Cardiothoracic surgery was consulted, and no surgical intervention for the retained fragment was recommended due to the patient being considered a very poor candidate.Three days later, the non-bsc heart pump was removed due to the development of anemia.The patient remained on supportive therapies and ventilator support.On the next day, the patient acutely and rapidly decompensated and died; the family had previously decided that care would not be escalated if cardiac arrest occurred.
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.Investigation results: device analysis findings: the device was not returned; therefore, a technical analysis could not be performed.Device history record 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: a risk review was performed, and it confirmed that the events are defined in the risk documentation and is recorded accordingly in the product record review (prr) table.This event types have 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 cause not established.This code was selected as the most probable complaint cause based on the information available.It was reported that during the procedure the synergy xd balloon ruptured at six atmospheres.The stent and balloon could not be withdrawn.The proximal portion of the balloon was retracted out of the newly under-deployed stent.Multiple attempts were made to retrieve the retained equipment using wire escalation and a microcatheter.The patient subsequently experienced cardiac arrest, after which a non-bsc heart pump and temporary pacing wire were placed.The physician made several unsuccessful snare attempts to retrieve the retained balloon fragment from the ascending aorta.The patient was then admitted to the icu.Cardiothoracic surgery was consulted, and no surgical intervention for the retained fragment was recommended due to the patient being considered a very poor candidate.The patient's family had previously decided that care would not be escalated if cardiac arrest occurred.The patient later died.The exact cause of the initial balloon rupture could not be established.The retrieval difficulties, post balloon rupture, are likely due to the fact the stent did not fully expand, due the synergy balloon not reaching its nominal pressure (11 atmospheres).Also, when a rupture occurred in the balloon, the physician's ability to achieve a vacuum in order to fully deflate the balloon would have been compromised which likely resulted in excessive tensile forces being applied to the device, during withdrawal attempts, resulting in the reported shaft break.It is noted per the product's instructions for use (ifu) that the event of death is listed as a known adverse event associated with device use.
Event or Problem Description
It was reported via medwatch mw5182566 that the patient died.The patient presented with coronary artery disease with unstable angina admitted for elective left heart catheterization.A 2.50 x 28mm synergy? xd drug-eluting stent was advanced for treatment using a non-boston scientific (non-bsc) guide extension catheter.However, during the inflation at six atmospheres the stent delivery system balloon ruptured.The stent and balloon could not be withdrawn through an older proximal stent.The proximal portion of the balloon was retracted out of the newly under-deployed stent.Multiple attempts were made to retrieve the retained equipment using wire escalation and a microcatheter.The patient subsequently experienced cardiac arrest, after which a non-bsc heart pump and temporary pacing wire were placed.The physician made several unsuccessful snare attempts to retrieve the retained balloon fragment from the ascending aorta.The patient was then admitted to the icu.Cardiothoracic surgery was consulted, and no surgical intervention for the retained fragment was recommended due to the patient being considered a very poor candidate.Three days later, the non-bsc heart pump was removed due to the development of anemia.The patient remained on supportive therapies and ventilator support.On the next day, the patient acutely and rapidly decompensated and died; the family had previously decided that care would not be escalated if cardiac arrest occurred.

• 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: 24344397
• Report Number: 2124215-2026-08470
• Device Sequence Number: 9523196
• Product Code: NIQ
• UDI-Device Identifier: 08714729980834
• UDI-Public: (01)08714729980834(17)270423(10)36459785
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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 Model Number: H7493941828250
• Device Catalogue Number: H7493941828250
• Device Lot Number: 0036459785
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 04/23/2025
• 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; Death; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 85 KG