MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM) PLC201000 manufactured by W.l. Gore & Associates.
| Report Number | 3013164176-2020-00044 |
| MDR Report Key | 9887454 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-28 |
| Device Manufacturer Date | 2019-11-25 |
| Date Added to Maude | 2020-03-27 |
| 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 | JOERG KERSTEN |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL SILICON VALLEY B/P |
| Manufacturer Street | 2890 DE LA CRUZ BLVD. |
| Manufacturer City | SANTA CLARA CA 95050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM) |
| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2020-03-27 |
| Model Number | PLC201000 |
| Catalog Number | PLC201000 |
| Lot Number | 21379231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |