MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) PLC181200J manufactured by W.l. Gore & Associates.
[188207131]
According to the instructions for use (ifu) for the gore? Excluder? Aaa endoprosthesis; adverse events that may occur include, but are not limited to: occlusion of device or native vessel. A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Patient Sequence No: 1, Text Type: N, H10
[188207132]
On (b)(6) 2020, this patient underwent endovascular treatment of an abdominal aortic aneurysm and was implanted with gore? Excluder? Aaa endoprostheses featuring c3? Delivery system. Post deployment of the trunk ipsilateral leg component, a contralateral leg component was implanted on the contralateral side and unintentionally covered the left internal iliac artery (liia). The physician attempted to maneuver the device proximally and to correct the coverage of the liaa but was unsuccessful. The patient tolerated the procedure and will be monitored by the physician. The physician commented that the length to the iliac artery bifurcation was 9. 5 cm with tortuosity and a longer length was chosen; however the anatomy was straightened by the stiff wire thus contributing the unintentional coverage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013164176-2020-00042 |
| MDR Report Key | 9886887 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-13 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2020-03-26 |
| 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 | LAURA CRAWFORD |
| 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 PROFILE) |
| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2020-03-26 |
| Catalog Number | PLC181200J |
| Lot Number | 20775664 |
| 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 | 1. Hospitalization; 2. Other | 2020-03-26 |