MAUDE Adverse Event Report: STENT, CORONARY

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Myocardial Infarction (1969)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Reporter states that in 2014 he had an operation to have a stent implanted.Two years later in (b)(6) 2016, the stent moved from its original position and caused a blood clot that led to a severe heart attack.On (b)(6) 2016 he underwent bypass surgery and had the stent removed.He is unsure of the mfr of the stent.

• Brand Name: STENT, CORONARY
• Type of Device: STENT, CORONARY
• MDR Report Key: 7376920
• MDR Text Key: 103829992
• Report Number: MW5076189
• Device Sequence Number: 1
• Product Code: MAF
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 61 YR
• Patient Weight: 64