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

Model Number	H7493941838250
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) 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 completed and confirmed that the event of dark spots in the image of the device was defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of cause not established.This conclusion code is based on the available information and the record review conducted.Based on the limited available information and lack of procedural detail it cannot be assessed at this time what may have contributed to the reported issue and the cause cannot be established.A review of the product record did not identify any issues during the manufacturing of the finished goods batch which may have contributed to the event.The imaging required and additional devices used were due to procedural conditions.
Event or Problem Description
It was reported via medwatch mw5182484 that stenting issues occurred.The patient presented with non-st elevation myocardial infarction.The target lesion was located in the right coronary artery.A non-boston scientific guidewire was placed.One stent was successfully delivered but when attempting to place a 2.50 x 38 mm synergy xd stent distal to the first stent, the 2.50 x 28 mm synergy xd became entrapped in the proximal vessel.It could not be removed or advanced.After multiple removal attempts the stent was able to be removed from the body.Further imaging showed the retained stent and/or a wire fragment in the vessel and aorta.Inspection of the removed equipment showed significant distortion of the stent and shearing of the wire.The part extending into the aorta was cut and removed.No wire was retained.There were no patient complications reported.It was further reported the first implanted stent was a 2.50 x 48 mm synergy xd.No damage was noted to it and this stent remained implanted in its intended location.
Event or Problem Description
It was reported via medwatch mw5182484 that stenting issues occurred.The patient presented with non-st elevation myocardial infarction.The target lesion was located in the right coronary artery.A non-boston scientific guidewire was placed.One stent was successfully delivered but when attempting to place a 2.50 x 38 mm synergy xd stent distal to the first stent, the 2.50 x 28 mm synergy xd became entrapped in the proximal vessel.It could not be removed or advanced.After multiple removal attempts the stent was able to be removed from the body.Further imaging showed the retained stent and/or a wire fragment in the vessel and aorta.Inspection of the removed equipment showed significant distortion of the stent and shearing of the wire.The part extending into the aorta was cut and removed.No wire was retained.There were no patient complications reported.
Additional Manufacturer Narrative
H11 additional mfr narrative - investigation results - risk review: corrected investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) 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 (prr) 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 cause not established.This conclusion code is based on the available information and the record review conducted.Based on the limited available information and lack of procedural detail it cannot be assessed at this time what may have contributed to the reported issue and the cause cannot be established.A review of the product record did not identify any issues during the manufacturing of the finished goods batch which may have contributed to the event.The imaging required and additional devices used were due to procedural conditions.
Event or Problem Description
It was reported via medwatch mw5182484 that stenting issues occurred.The patient presented with non-st elevation myocardial infarction.The target lesion was located in the right coronary artery.A non-boston scientific guidewire was placed.One stent was successfully delivered but when attempting to place a 2.50 x 38 mm synergy xd stent distal to the first stent, the 2.50 x 28 mm synergy xd became entrapped in the proximal vessel.It could not be removed or advanced.After multiple removal attempts the stent was able to be removed from the body.Further imaging showed the retained stent and/or a wire fragment in the vessel and aorta.Inspection of the removed equipment showed significant distortion of the stent and shearing of the wire.The part extending into the aorta was cut and removed.No wire was retained.There were no patient complications reported.It was further reported the first implanted stent was a 2.50 x 48 mm synergy xd.No damage was noted to it and this stent remained implanted in its intended location.

• 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: 24512009
• Report Number: 2124215-2026-11923
• Device Sequence Number: 21454100
• Product Code: NIQ
• UDI-Device Identifier: 08714729980858
• UDI-Public: (01)08714729980858(17)270526(10)36635936
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: H7493941838250
• Device Catalogue Number: H7493941838250
• Device Lot Number: 0036635936
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 04/01/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/02/2026
• Date Device Manufactured: 05/26/2025
• 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
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Race: White