FDA Adverse Event
Other
Summary report: N
ANACONDA
MDR report key: 2426272
·
Received January 17, 2012
Report
- Report Number
- 9612515-2012-00001
- Event Type
- Other
- Date Received
- January 17, 2012
- Date of Event
- December 16, 2012
- Report Date
- January 17, 2012
- Manufacturer
- VASCUTEK LTD.
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: VASCUTEK WILL CARRY OUT AN INVESTIGATION INTO THE EXPLANTED GRAFT AND REPORT THE FINDINGS IN THE FOLLOW-UP REPORT. VASCUTECK WILL REVIEW THE OCCURRENCE OF OCCLUSIONS. SUSPECT MEDICAL DEVICE - ADDITIONAL DEVICES USED IN THE EVENT: CATALOGUE NUMBER: B23*02, LOT NUMBER: 11502643 2470 AND SERIAL NUMBER: (B)(4). CATALOGUE NUMBER: FL1215X110*02, LOT NUMBER: 11551805 2340 AND SERIAL NUMBER: (B)(4) (RIGHT LIMB).
Description of Event or Problem · 1
AN EVENT OCCURRED AT LITTLE (B)(6) IN THE USA. SURGEON DR (B)(6) WITH DR. (B)(6) PRESENT. THE EVENT WAS INTERVENTION TO EXPLANT A VASCUTEK EVAR DEVICE. VASCUTEK BECAME AWARE OF THE EVENT ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANACONDA | AAA STENT GRAFT SYSTEM | DSY | VASCUTEK LTD. | UNK | 11738222 2446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |