MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. SYNERGY MONORAIL EVEROLIUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number H7493926038250

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/02/2020

Event Type  Injury  

Event Description

Stent balloon became stuck inside pt's coronary artery.Balloon broke off of delivery shaft and remained inside pt's heart.Cardiothoracic surgeon was consulted and situation was treated by stenting the remaining balloon fragment against the wall of the coronary artery.Subsequently, pt had to undergo tf tavr (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: SYNERGY MONORAIL EVEROLIUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 9800195
• MDR Text Key: 182621908
• Report Number: MW5093564
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: (01)08714729840398
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926038250
• Device Catalogue Number: H7493926038250
• Device Lot Number: 23854187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 79 YR
• Patient Weight: 73