MAUDE Adverse Event Report: DRUG ELUTING STENT PCI; CORONARY DRUG - ELUTING STENT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Arrest (1762)

Event Date 05/30/2018

Event Type  Injury  

Event Description

Had a heart attack, they put in a stent called drug eluting stent then had another put in on (b)(6) 2018 the last one was (b)(6) 2018 that led to open heart and icd.Fda safety report id# (b)(4).

• Brand Name: DRUG ELUTING STENT PCI
• Type of Device: CORONARY DRUG - ELUTING STENT
• MDR Report Key: 8555749
• MDR Text Key: 143450937
• Report Number: MW5086217
• 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: Patient
• Type of Report: Initial
• Report Date: 04/23/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: INSERTION OF AV SEQUENTIAL ICD MODEL MEDTRONIC DDMB1D4, SERIAL #(B)(4)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 76