MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-03-26 for AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) RLT281418 manufactured by W.l. Gore & Associates.
[188886368]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188886369]
The following information was reported to gore through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2016 a patient underwent treatment of an abdominal aortic aneurysm and a left internal iliac aneurysm with gore? Excluder? Aaa endoprostheses. The maximum aortic diameter was 58. 6mm. On (b)(6) 2016 the maximum aortic diameter by ct was 65mm. On (b)(6) 2019 the maximum aortic diameter by cta was 55mm. A type 1b endoleak was discovered in the right common iliac artery. Proximal migration of the graft limb into the aortic sac was also reported. On (b)(6) 2020 a reintervention took place with extension of the endoprosthesis. On march 12, 2020 the type 1b endoleak was deemed as resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2020-00077 |
| MDR Report Key | 9885461 |
| Report Source | STUDY |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2016-08-02 |
| Device Manufacturer Date | 2015-07-06 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HEIDI INSKEEP |
| 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 | 2020-03-26 |
| Model Number | RLT281418 |
| Catalog Number | RLT281418 |
| Lot Number | 14048651 |
| Device Expiration Date | 2018-07-05 |
| 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; 3. Required No Informationntervention | 2020-03-26 |