DeathMIH
THORACIC STENT
Received Apr 5, 2022 · Event occurred Dec 25, 2021
Report MW5108768 · MDR key 14021263
Device
Generic name
System, Endovascular Graft, Aortic Aneurysm Treatment
Manufacturer
Medtronic Mexico EgProduct problems
- Leak/Splash
- Nonstandard Device
Patient
72 YR · Male
- Unspecified Infection
- Sepsis
- Perforation of Esophagus
- Unspecified Infection
- Sepsis
- Perforation of Esophagus
Narrative
Description of Event or Problem
STENT LEAKED AND CAUSED AN INFECTION WHICH TORE A HOLE IN HIS ESOPHAGUS AND CAUSE MY PARTNER TO BE SEPTIC. HE HAD OTHER HEALTH ISSUES BUT IF HE WASN'T SEPTIC, HE WOULD HAVE BEEN WITH US LONGER. WE DIDN'T RECEIVE CERTIFIED LETTER STATING THERE WAS A RECALL. THE STENTS USED WERE (B)(4). FDA SAFETY REPORT ID# (B)(4).