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 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) YRBR2816165 manufactured by Medtronic Vascular.
[489325]
A 28 cm diameter x 16 mm diameter x 16. 5 cm length aneurx bifurcated stent graft and its components were implanted in a pt for the endovascular treatment of an abdominal aortic aneurysm. Aneurysm and vessel morphology are unk. It was reported that the approx 9 months post stent graft implant the pt had a type ii endoleak and elected to have no further intervention at that time. The pt was lost to follow-up until 74 months after stent graft implant. The pt presented emergently with severe back pain. The ct demonstrated that the aorta was leaking at an unk location. The emergency room physician assumed the aorta had ruptured. The physician elected to repair the aorta with open surgical repair with a conventional stent graft. Upon removal, the physician notices that there was a type iii endoleak in the first 3-4cm of the stent graft. The stent graft has been received for analysis. No additional clinical sequelae were reported and the pt is fine.
Patient Sequence No: 1, Text Type: D, B5
[7777517]
Evaluation results - lack of info (aneurysm and vessel morphology are unk, pending device analysis). Inherent risk of procedure (aneurysm rupture). Pts condition affected effectiveness of device (the pt did not return for follow-up appointments). Conclusions: lack of info (aneurysm and vessel morphology are unk). Lack of effectiveness related to pt condition (the pt did not return for follow-up appointments).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953200-2006-00166 |
| MDR Report Key | 740972 |
| 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 | 2000-04-01 |
| 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 UNOVAL 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 | MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) |
| Generic Name | AAA STENT GRAFT |
| Product Code | NIH |
| Date Received | 2006-07-27 |
| Returned To Mfg | 2006-07-05 |
| Model Number | NA |
| Catalog Number | YRBR2816165 |
| Lot Number | M0078678 |
| ID Number | NA |
| Device Expiration Date | 2001-04-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 728840 |
| 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 |