MAUDE Adverse Event Report: STENT SYNERGY MR 3.00MM X 16MM H7493926016300 DRUG ELUTING STENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Atrial Fibrillation (1729); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Stenosis (2263)

Event Date 09/23/2018

Event Type  Injury  

Event Description

The pt experienced a lift-threatening gastrointestinal bleed (duodenal), which then strained his heart, causing ischemia.On (b)(6) 2018 er visit with new diagnosis of atrial fibrillation; (b)(6) admitted and started on warfarin and heparin, (b)(6) 2018 cardiac catheter with drug eluting stent started on plavix; (b)(6) bloody diarrhea, (b)(6) er visit finding gi bleed by ct and hemoglobin of 7.Medevac'd by air ambulance to (b)(6), where required egd and cardiac catheterization.Pulmonary hypertension, aortic stenosis, cad, atrial fibrillation, diastolic dysfunction for additional info, please contact (b)(6).

• Brand Name: STENT SYNERGY MR 3.00MM X 16MM H7493926016300 DRUG ELUTING STENT
• Type of Device: DRUG ELUTING STENT
• MDR Report Key: 7922594
• MDR Text Key: 122372749
• Report Number: MW5080228
• 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: Physician
• Type of Report: Initial
• Report Date: 09/27/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 80 YR
• Patient Weight: 94