ZENITH FLEX AAA ENDOVASCULAR GRAFT Adverse Event — Injury (MDR 1820334-2008-00100)
ZENITH FLEX AAA ENDOVASCULAR GRAFT Adverse Event — Injury (MDR 1820334-2008-00100) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ZENITH FLEX AAA ENDOVASCULAR GRAFT; Generic name: MIH ENDOVASCULAR GRAFT; Manufacturer: COOK INCORPORATED.
| Device | ZENITH FLEX AAA ENDOVASCULAR GRAFT |
|---|---|
| Generic name | MIH ENDOVASCULAR GRAFT |
| Manufacturer | COOK INCORPORATED |
| Report number | 1820334-2008-00100 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-21 |
| Report source | Health Professional, Company representation |
| Narrative | A MALE PATIENT HAD INITIAL AAA REPAIR IN 2007. ONE FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. THE MAIN BODY WAS INADVERTENTLY PLACED LOW, BUT DID NOT IMMEDIATELY SHOW AN ENDOLEAK. THE FIRST CT SHOWED A TYPE I ENDOLEAK. THE PHYSICIAN DECIDED TO USE A MAIN BODY EXTENSION GRAFT IN 2008, TO ADDRESS THE ENDOLEAK AS THE PATIENT HAD A RENAL STENT THAT EXTENDED AT LEAST 5MM INTO THE LUMEN OF THE |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →