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) RLT231218 manufactured by W.l. Gore & Associates.
[185993272]
Additional system components involved in this adverse event include: item #pla230300/ lot #12369248/ udi # (b)(4). Item #pxc121200/ lot #14277059/ udi # (b)(4). Images were provided, and an imaging evaluation was performed. The review of the manufacturing paperwork verified that the lot met all pre-release specifications. The imaging evaluation stated the following: the length from the lowest renal to the proximal end of the device appears to be ~18 mm. The lesion appears to be immediately distal to the lowest renal. There doesn? T appear to be proximal wall apposition? Proximal type i endoleak. Received one time-point for review.
Patient Sequence No: 1, Text Type: N, H10
[185993273]
On (b)(6) 2016 the patient underwent endovascular treatment using gore? Excluder? Aaa endoprostheses. The patient was reportedly lost to follow-up. On (b)(6) 2020 the patient presented with abdominal pain. Ct imaging identified a proximal type i endoleak. Aneurysm enlargement was reported. Amount of enlargement is reportedly unavailable. It was reported that the patient's aortic neck was short. No further information regarding the patient's anatomy was available. The endoleak was reportedly suspected to be caused by the patient's short angle aortic neck. Reportedly the physician opted to explant all three implanted gore? Excluder? Aaa endoprostheses, including a trunk-ipsilateral leg component, an aortic extender component, and a contralateral leg component. It was reported that the devices were explanted due to the endoleak and the amount of aneurysm enlargement, as well as the short angle of the patient's aortic neck not allowing for additional treatment options. The patient tolerated the explant procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2020-00083 |
| MDR Report Key | 9901419 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-02 |
| Device Manufacturer Date | 2015-07-22 |
| 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 | JENNA LOPEZ |
| 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 | RLT231218 |
| Catalog Number | RLT231218 |
| Lot Number | 14105847 |
| Device Expiration Date | 2018-07-21 |
| 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. Required No Informationntervention | 2020-03-30 |