MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-07-27 for ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM YRBRHXC2615165 manufactured by Medtronic Vascular.
[473549]
A 26 mm diameter x 15 mm diameter x 16. 5 cm length aneurx bifurcated stent graftt and its components were implanted in a pt for the endovascular treatment of an abdominal aortic aneurysm. Aneurysm morphology at the time of implant is unk. It was reported that 8 months post implant the pt was in for follow-up appointment. The ct demonstrated that due to by disease progression resulting in dilatation of the aortic neck the stent graft has migrated. The physician elected to implant another mfr's aortic cuff. No additional clinical sequelae were reported and the pt is fine.
Patient Sequence No: 1, Text Type: D, B5
[7842131]
Evaluation results - lack of info (no operation reports or films are available). Lack of effectiveness related to pt condition (dilated aortic neck).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953200-2006-00167 |
| MDR Report Key | 740985 |
| Report Source | 05,07 |
| Date Received | 2006-07-27 |
| Date of Report | 2006-06-27 |
| Date of Event | 2006-06-27 |
| Date Mfgr Received | 2006-06-27 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2006-07-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | VIRANDER SINGH |
| Manufacturer Street | 3576 UNOCAL PLACE |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal | 95403 |
| Manufacturer Phone | 7075917261 |
| Manufacturer G1 | MEDTRONIC VASCULAR |
| Manufacturer Street | 3576 UNOCAL PLACE |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM |
| Generic Name | AAA STENT GRAFT |
| Product Code | NIH |
| Date Received | 2006-07-27 |
| Model Number | NA |
| Catalog Number | YRBRHXC2615165 |
| Lot Number | 596236 |
| ID Number | NA |
| Device Expiration Date | 2007-05-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 728853 |
| Manufacturer | MEDTRONIC VASCULAR |
| Manufacturer Address | 3576 UNOCAL PL. SANTA ROSA CA 95403 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-07-27 |