MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for OVATION IX TV-AB2680-I manufactured by Endologix Santa Rosa.
[188332593]
The device involved in this 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.
Patient Sequence No: 1, Text Type: N, H10
[188332594]
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm. Post polymer fill of the aortic body stent graft, the patient experienced hypotension and was successfully treated for an anaphylactic reaction per the device ifu. As no polymer appeared in the proximal rings, a medtronic (non-endologix) proximal stent and an addition ovation limb were implanted. The case concluded without additional negative patient sequelae and the aneurysm was excluded. The patient will continue to be monitored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008011247-2020-00051 |
| MDR Report Key | 9908795 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-09-11 |
| 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 | 3910 BRICKWAY BLVD , |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal | 95403 |
| Manufacturer Phone | 8009832284 |
| Manufacturer G1 | ENDOLOGIX SANTA ROSA |
| Manufacturer Street | 3910 BRICKWAY BLVD , |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95403 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVATION IX |
| Generic Name | AORTIC BODY |
| Product Code | MIH |
| Date Received | 2020-03-31 |
| Model Number | TV-AB2680-I |
| Lot Number | FS081219-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOLOGIX SANTA ROSA |
| Manufacturer Address | 3910 BRICKWAY BLVD , SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |