MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD MONORAIL EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Catalog Number	H7493941824270
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Discomfort (2330); Respiratory Arrest (4461)
Date of Event	03/24/2025
Type of Reportable Event	Death
Event or Problem Description
Patient arrived in cath lab for a cardiac catheterization.Procedure began with access to the right groin and diagnostic imaging showed a lesion in the proximal lad.Lesion was predilated with a 2.0 x 20mm takeru balloon.A 2.75 x 24mm synergy des was then passed down and across the lesion.Stent deployed to 20 atms.Upon attempted removal of delivery catheter, resistance was met.Catheter then released and was removed where it was noted the catheter was broken.Angiography showed the balloon markers were still in the vessel.Patient began to complain of chest discomfort and patient was intubated.Vascular surgeon was called to assist and successfully retrieved broken piece from body.Patient distress continued to escalate.Cardiac and respiratory arrest shortly followed.Cpr began and attempts to place an impella device unsuccessful.Patient expired in cath lab.

• Brand Name: SYNERGY XD MONORAIL EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 21797169
• Report Number: MW5168702
• Device Sequence Number: 8210326
• Product Code: NIQ
• UDI-Device Identifier: 08714729980902
• UDI-Public: (01)08714729980902(17)260415(10)33881804
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: 04/15/2026
• Device Catalogue Number: H7493941824270
• Device Lot Number: 33881804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White