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 2020-03-23 for AXIUM PRIME BRPL HLX APB-2-4-HX-ES manufactured by Micro Therapeutics, Inc. Dba Ev3.
[184490774]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184490775]
Medtronic received a report that the axium coil did not have a coil at the tip side. A different coil was used for the procedure, and there was no patient harm reported. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the posterior communicating (pcom) artery with a max diameter of 4. 56mm and a 2. 78mm neck diameter. It was noted the patient's blood flow and vessel tortuosity were normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00280 |
| MDR Report Key | 9865987 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-11-22 |
| Date Added to Maude | 2020-03-23 |
| 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 | KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIUM PRIME BRPL HLX |
| Generic Name | DEVICE, EMBOLIZATION, VASCULAR |
| Product Code | KRD |
| Date Received | 2020-03-23 |
| Model Number | APB-2-4-HX-ES |
| Catalog Number | APB-2-4-HX-ES |
| Lot Number | A936444 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |