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 2019-04-24 for WEB LOW PROFILE SL FGA25060-030 manufactured by Sequent Medical, Inc.
[142947685]
The lot number was provided. A review of the approved device history records indicated the lot met all release criteria. A lot history trending review was performed and there were no similar complaints for this lot number. The device was not returned to the manufacturer for evaluation; therefore, a product analysis could not be performed. The root cause is unknown. The device was used during the same procedure as was reported on mfr. Report number 2032493-2019-00107.
Patient Sequence No: 1, Text Type: N, H10
[142947686]
It was reported that during treatment of an anterior communicating artery aneurysm with the web device, the aneurysm ruptured. As reported, there was no difficulty advancing the catheter or web device. There was noted angulation between the aneurysm and the vessel. During deployment of the web device within the sac, the physician started to unsheathe the web device, the system moved proximally toward the neck and the web was partially deployed. It was noted that the web was not deploying as expected and a subsequent contrast injection demonstrated extravasation at the neck of the aneurysm. The web was retracted and removed together with the via microcatheter. A scepter balloon was advanced and placed to occlude the aneurysm, and a ventricular shunt was placed. Once the bleeding was controlled, the procedure was completed with balloon-assisted coil embolization of the aneurysm. Immediately following the procedure, a ct was performed, and the patient was taken back to the or for additional placement of a ventricular shunt. Patient status was unknown at the time of the report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2019-00106 |
| MDR Report Key | 8545775 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-24 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2019-03-04 |
| Date Added to Maude | 2019-04-24 |
| 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 | MS. DEBBY CALLAHAN |
| Manufacturer Street | 35 ENTERPRISE DRIVE |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEB LOW PROFILE SL |
| Generic Name | WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM |
| Product Code | OPR |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-03-29 |
| Model Number | FGA25060-030 |
| Catalog Number | FGA25060-030 |
| Lot Number | 19030423 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEQUENT MEDICAL, INC |
| Manufacturer Address | 11 A COLUMBIA ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention | 2019-04-24 |