FDA Adverse Event
Injury
Summary report: N
EXCLUDER BIFURCATED ENDOPROSTHESIS
MDR report key: 473583
·
Received July 23, 2003
Report
- Report Number
- 2953161-2003-00022
- Event Type
- Injury
- Date Received
- July 23, 2003
- Date of Event
- April 10, 2003
- Report Date
- July 22, 2003
- Manufacturer
- W.L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE TRUNCK-IPSILATERAL LEG COMPONENT OF THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE) WAS DELIVERED WITHOUT DIFFICULTY. DURING CANNULATION OF THE CONTRALATERAL LEG HOLE, IT WAS DETERMINED THAT THE RIGHT ILIAC ARTERY HAD BEEN PERFORATED BY THE GUIDEWIRE THAT WAS NOTED TO BE EXTRAVASCULAR. PATIENT'S BLOOD PRESSURE DROPPED TO 75MM HG SYSTOLIC. A 33MM BALLOON WAS ADVANCED TO THE PROXIMAL END OF THE EBE AT WHICH TIME THE PATIENT'S PRESSURE RETURNED TO 110MM HG. THE CONTRALATERAL LIMB WAS THEN DEPLOYED, EFFECTIVELY SEALING THE ILIAC PERFORATION. ESTIMATED BLOOD LOSS WAS +200CC (INTERNAL). PATIENT RECEIVED ONE UNIT OF BLOOD AND TWO LITERS OF CRYSTALLOIDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCLUDER BIFURCATED ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W.L. GORE & ASSOCIATES, INC. | WLG325 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |