MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-11-30 for EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT & DELIVERY NT356402D NA manufactured by Edwards Lifesciences.
[415094]
Reportedly stent was deployed in the superficial femoral artery. The stent moved forward and compressed. Because of the compression the lesion was not covered completely, so another stent was put in. No further info provided. No device returned for evaluation. Note: this device was being used off label as it is approved for use in the biliary tree.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000002-2005-00677 |
| MDR Report Key | 648502 |
| Report Source | 06,07 |
| Date Received | 2005-11-30 |
| Date of Report | 2005-11-07 |
| Date of Event | 2005-11-07 |
| Date Facility Aware | 2005-11-07 |
| Date Mfgr Received | 2005-11-07 |
| Date Added to Maude | 2005-12-05 |
| 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 | 3 |
| Manufacturer Contact | ALLISON MEZZANATTO |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502562 |
| Manufacturer G1 | EDWARDS LIFESCIENCES |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT & DELIVERY |
| Generic Name | BILIARY STENT |
| Product Code | FGF |
| Date Received | 2005-11-30 |
| Model Number | NT356402D |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 637990 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US |
| Baseline Brand Name | EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT & DELIVERY |
| Baseline Generic Name | BILIARY STENT |
| Baseline Model No | NT356402D |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-30 |