MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC SYNERGY 2.50X38MM DRUG ELUTING CORONARY MONORAIL STENT; CORONARY DRUG-ELUTING STENT

Model Number 08714729840398

Device Problems Material Separation (1562); Malposition of Device (2616); Therapeutic or Diagnostic Output Failure (3023); Activation Problem (4042)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 11/11/2019

Event Type  malfunction  

Event Description

During the course of a pci to the mid circumflex artery, the coronary stent delivery system malfunctioned resulting in a partially deployed stent which was misplaced and separated catheter segment.Both the stent and the piece of the delivery system was ultimately retrieved from the pt; however, the pt suffered a neurological event post procedure.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC SYNERGY 2.50X38MM DRUG ELUTING CORONARY MONORAIL STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 9341010
• MDR Text Key: 167168128
• Report Number: MW5091142
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 08714729840398
• Device Catalogue Number: H7493926038250
• Device Lot Number: 23241457
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 55 YR
• Patient Weight: 105