MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-24 for PIPELINE NV UNK PIPELINE manufactured by Micro Therapeutics, Inc. Dba Ev3.
[184697075]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184697076]
Kunal vakharia,muhammad waqas,hakeem j shakir,felix chin, joelle n hartke,1 hussain shallwani, jeffrey s beecher, adnan h siddiqui, elad i levy. Versatile use of catheter systems for deployment of the pipeline embolization device: a comparison of biaxial and triaxial catheter systems. Doi:10. 1136/ neurintsurg-2019-015610. Medtronic literature review found a report of complications after the use of pipeline. The purpose of the article was to compare the use of biaxial or triaxial catheter delivery systems for intracranial aneurysm treatment with the ped. The mean? Sd age of the patients in the catheter system groups were comparable (55. 8? 14. 3 years in the biaxial group vs 56. 0? 13. 1 years in the triaxial group). - one patient death occurred in the biaxial group. The patient had presented with hunt and hess grade 4 subarachnoid hemorrhage due to a ruptured blister supraclinoid dorsal carotid wall aneurysm. The aneurysm was the only one in our cohort that was treated with a ped acutely in the setting of subarachnoid hemorrhage because of the morphology and location of the aneurysm. The patient? S neurological status did not improve after ped deployment. The patient developed severe vasospasm of the middle cerebral artery and continued to decline in neurological status. Care was discontinued according to the family? S wishes on the basis of the patient? S living will.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00291 |
| MDR Report Key | 9873120 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-24 |
| 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 | PIPELINE |
| Generic Name | INTRACRANIAL ANEURYSM FLOW DIVERTER |
| Product Code | OUT |
| Date Received | 2020-03-24 |
| Model Number | NV UNK PIPELINE |
| Catalog Number | NV UNK PIPELINE |
| Lot Number | NOT-RPT |
| 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 | 1. Death | 2020-03-24 |