MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) RLT351414 manufactured by W.l. Gore & Associates.
[188892314]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188892315]
On (b)(6) 2017, the patient was implanted with a gore? Excluder? Aaa endoprostheses to treat an abdominal aortic aneurysm (evar). The patient tolerated the procedure. It was reported that the gore? Excluder? Aaa endoprosthesis (rlt351414/16321885) appeared to migrate distally on recent computed tomography (ct) follow up (date is unknown). The endoprosthesis was approximately 2cm distal from the right renal artery. The right renal artery was previously stented prior to evar procedure in 2017. The right renal artery is now occluded and atrophic. On (b)(6) 2020, the physician reintervened and two gore? Excluder? Aaa aortic extender endoprostheses (pla360400) were placed via left access up to the level of the left renal artery. The patient tolerated the reintervention. No proximal type 1 endoleak was noted on angio. The size of the aortic neck is unknown. The angulation was less than 60 degrees infrarenal. The cause of the migration is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2020-00082 |
| MDR Report Key | 9901198 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Device Manufacturer Date | 2017-05-19 |
| Date Added to Maude | 2020-03-30 |
| 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 | RACHAEL CHASCSA |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL PHOENIX 2 B/P |
| Manufacturer Street | 32470 N. NORTH VALLEY PARKWAY |
| Manufacturer City | PHOENIX AZ 85085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) |
| Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Product Code | MIH |
| Date Received | 2020-03-30 |
| Model Number | RLT351414 |
| Catalog Number | RLT351414 |
| Lot Number | 16321885 |
| 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. Required No Informationntervention | 2020-03-30 |