MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for AFX BA25-100/I16-40 manufactured by Endologix.
[188693591]
The device involved in the event will not be returned for evaluation as it remains implanted in the patient. Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist. If additional information pertinent to the incident is obtained, a follow-up report will be submitted. ? Device iteration is afx with strata?.
Patient Sequence No: 1, Text Type: N, H10
[188693592]
The patient was initially implanted with a bifurcated stent graft and suprarenal extension to treat an abdominal aortic aneurysm (aaa). Approximately six and a half (6. 5) years post initial procedure, the patient presented with a possible type 3b endoleak. Patient is pending an angiogram to confirm endoleak and if confirmed physician will re-intervene with a re-line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031527-2020-00118 |
| MDR Report Key | 9905115 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2013-03-19 |
| Date Added to Maude | 2020-03-31 |
| 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 | MR. EMILE PINSONNEAULT |
| Manufacturer Street | 2 MUSICK , |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 8009832284 |
| Manufacturer G1 | ENDOLOGIX |
| Manufacturer Street | 2 MUSICK , |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0006-2019 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFX |
| Generic Name | BIFURCATED STENT GRAFT |
| Product Code | MIH |
| Date Received | 2020-03-31 |
| Model Number | BA25-100/I16-40 |
| Lot Number | 1048777-017 |
| Device Expiration Date | 2016-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOLOGIX |
| Manufacturer Address | 2 MUSICK , IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |