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

Model Number	H7493941824350
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dislodgment occurred resulting in additional intervention.The target lesion was located in the right coronary artery (rca).Following pre-dilation with a 2.50 x 15 mm emerge balloon catheter, the 3.50 x 24 mm synergy xd drug-eluting stent was advanced but was unable to cross the lesion.A 3.50 x 15 mm nc emerge was then used to pre-dilate the rca along with a non-boston scientific (non-bsc) guide extension catheter for better support.The 3.50 x 24 mm synergy xd was re-introduced but was still unable to cross the lesion.During retrieval, the stent delivery system (sds) was difficult to remove.The device looked to be buckling proximally on the diseased vessel or the guide catheter, and the distal end of the stent appeared to be off the balloon.When the sds was eventually removed and was inspected, there was no stent on the balloon.The undeployed stent was visible in the proximal rca, lodged in the diseased vessel.A 3.50 x 15 mm nc emerge balloon was used to further pre-dilate the vessel and embed the unexpanded stent in the vessel wall.A 3.50 x 28 mm synergy xd was advanced down the rca and deployed.The rca was patent and the unexpanded 3.50 x 24 mm synergy xd was secured to the vessel wall by the 3.50 x 28 mm synergy xd.The patient was not harmed and there were no negative outcomes from this occurrence.The patient is expected to fully recover.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the 3.50 x 24mm synergy xd mr us stent delivery system was returned for analysis without the stent.A visual and tactile inspection identified no kinks or damages with the hypotube.A microscopic examination of the balloon material was performed and there were crimp markings visible on the balloon profile.Balloon cones were reviewed and were not subjected to positive pressure.The bumper tip showed no signs of distal tip damage.The inner shaft polymer extrusion was bunched 6.4cm from the distal tip.A microscopic examination of the distal and proximal markerbands identified no damage.No other device issues were identified during returned product analysis.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 event was defined in the risk documentation and is recorded accordingly in the product record review table.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 procedure as it is most likely that procedural challenges, such as device interactions with other devices and interactions with potential patient anatomy likely contributed to the complaint event.This code was selected as the most probable complaint cause based on the information available.Device analysis confirmed the reported the reported stent dislodgment as no stent was returned.Crimp markings were visible on the balloon profile, and the balloon cones were not subjected to positive pressure.The inability to cross the rca lesion, combined with repeated advancement/withdrawal and increased friction during retrieval through a guide extension catheter, likely resulted in partial de crimping and subsequent separation of the stent from the balloon.The unreported inner shaft polymer extrusion damage likely occurred post procedure during removal of the guidewire.
Event or Problem Description
It was reported that dislodgment occurred resulting in additional intervention.The target lesion was located in the right coronary artery (rca).Following pre-dilation with a 2.50 x 15 mm emerge balloon catheter, the 3.50 x 24 mm synergy xd drug-eluting stent was advanced but was unable to cross the lesion.A 3.50 x 15 mm nc emerge was then used to pre-dilate the rca along with a non-boston scientific (non-bsc) guide extension catheter for better support.The 3.50 x 24 mm synergy xd was re-introduced but was still unable to cross the lesion.During retrieval, the stent delivery system (sds) was difficult to remove.The device looked to be buckling proximally on the diseased vessel or the guide catheter, and the distal end of the stent appeared to be off the balloon.When the sds was eventually removed and was inspected, there was no stent on the balloon.The undeployed stent was visible in the proximal rca, lodged in the diseased vessel.A 3.50 x 15 mm nc emerge balloon was used to further pre-dilate the vessel and embed the unexpanded stent in the vessel wall.A 3.50 x 28 mm synergy xd was advanced down the rca and deployed.The rca was patent and the unexpanded 3.50 x 24 mm synergy xd was secured to the vessel wall by the 3.50 x 28 mm synergy xd.The patient was not harmed and there were no negative outcomes from this occurrence.The patient is expected to fully recover.

• 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: 24463811
• Report Number: 2124215-2026-10886
• Device Sequence Number: 18494391
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: (01)08714729981060(17)270922(10)37600460
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: H7493941824350
• Device Catalogue Number: H7493941824350
• Device Lot Number: 0037600460
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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: Required Intervention
• Patient Sex: Unknown