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) RLT261416J manufactured by W.l. Gore & Associates.
[188989542]
Concomitant medical products and therapy dates - plc231000j/21238592, udi: (b)(4); plc201400j/21321445, udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188989563]
On (b)(6) 2020, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore? Excluder? Aaa endoprostheses featuring c3? Deployment system. After hemostasis, the color of the left leg seemed pale and the patient also had a weak pulse in the left leg. Therefore, peripheral angiography was performed which confirmed poor blood flow in the left superficial femoral artery due to thrombus. As treatment, a drug-eluting stent was implanted in the left superficial femoral artery. Also, percutaneous balloon angioplasty was performed in the region of the lower femoral artery. The patient tolerated the procedure. The physician noted that due to thrombus that was present in the left superficial femoral artery before the procedure, there was a possibility of dispersing thrombus/debris during the endovascular treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2020-00080 |
| MDR Report Key | 9898125 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-05 |
| Device Manufacturer Date | 2017-10-30 |
| 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 | DOUGLAS RHODES |
| 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 |
| Catalog Number | RLT261416J |
| Lot Number | 17386898 |
| 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 |