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

Model Number	H7493941816220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a dissection occurred.The 12 mm x 2.25 mm target lesion was located in the ramus intermedius (ri).The target lesion was pre-treated with a 2.00 mm x 12 mm non-compliant balloon angioplasty catheter resulting in 30% stenosis with timi flow 3.Following predilation, a 2.25 mm x 16 mm synergy xd drug eluting stent was deployed at 14 atm for 20 seconds.Post-deployment, a type c stent edge dissection was observed.The dissection was successfully treated with a 2.25 x 8mm non-boston scientific drug eluting stent.The patient was discharged the same day.
Event or Problem Description
It was reported that a dissection occurred.The 12 mm x 2.25 mm target lesion was located in the ramus intermedius (ri).The target lesion was pre-treated with a 2.00 mm x 12 mm non-compliant balloon angioplasty catheter resulting in 30% stenosis with timi flow 3.Following predilation, a 2.25 mm x 16 mm synergy xd drug eluting stent was deployed at 14 atm for 20 seconds.Post-deployment, a type c stent edge dissection was observed.The dissection was successfully treated with a 2.25 x 8mm non-boston scientific drug eluting stent.The patient was discharged the same day.
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 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 conclusion code of known inherent risk of device based upon the available information.Based on the medical review conducted for this complaint, the reported clinical event is anticipated per the ifu.The requirement for an additional device was due to procedural factors.

• 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: 25160542
• Report Number: 2124215-2026-25807
• Device Sequence Number: 16125962
• Product Code: NIQ
• UDI-Device Identifier: 08714729980728
• UDI-Public: (01)08714729980728(17)271126(10)38168309
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: H7493941816220
• Device Catalogue Number: H7493941816220
• Device Lot Number: 0038168309
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 11/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 193 LB