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 2020-02-14 for WEB LOW PROFILE SL-USA W4-4-3FOR US FGA25040-030 manufactured by Sequent Medical, Inc..
[183259669]
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device. The web was implanted and the delivery system was not returned for evaluation. The root cause cannot be determined. The instructions for use (ifu) identifies device migration, hemorrhage, parent artery occlusion, and vessel dissection or perforation as potential complications associated with the use of the device. The submission of this report or related information to the fda, and its release by the fda, does not reflect a conclusion by the party submitting this report or the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Patient Sequence No: 1, Text Type: N, H10
[183259670]
It was reported that treatment was performed for a right p-com aneurysm on a patient under conscious sedation. After uneventful placement of the web, imaging demonstrated a small amount of encroachment of the parent vessel. Delayed imaging demonstrated good flow within the parent artery [right internal carotid (rica)] and decreased flow into the aneurysm sac. The web was detached approximately 7 minutes after deployment. A subsequent neuro check was performed and the patient demonstrated weakness of the left upper extremity. 3-d reconstruction angiography demonstrated reduced flow in the rica and web migration from the aneurysm sac into the distal right mca-m1 segment. There was total occlusion of the right mca branches and outflow. Attempts were made with multiple devices to retrieve the web; however, all efforts were unsuccessful. A stent was implanted to compress the web against the m1 vessel, and in-stent balloon inflations were performed; however, there was only slight increase in flow. The m1 vessel appeared to have a new vessel dissection with associated extravasation at the site of the balloon inflations. Ten (10) embolization coils were implanted to sacrifice the parent vessel to occlude the extravasation. Final angiogram demonstrated total occlusion of the mca vessel and outflow. The patient was intubated and transferred to the neuro-icu. The patient is reported to be in critical condition and still on a ventilator at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2020-00033 |
| MDR Report Key | 9714819 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-01-28 |
| Date Added to Maude | 2020-02-14 |
| 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. EVA MANUS |
| Manufacturer Street | 35 ENTERPRISE DRIVE |
| Manufacturer City | ALISO VIEJO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEB LOW PROFILE SL-USA W4-4-3FOR US |
| Generic Name | INTRASACCULAR FLOW DISRUPTION DEVICE |
| Product Code | OPR |
| Date Received | 2020-02-14 |
| Model Number | FGA25040-030 |
| Catalog Number | FGA25040-030 |
| Lot Number | 19012816 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEQUENT MEDICAL, INC. |
| Manufacturer Address | 11 A COLUMBIA ALISO VIEJO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention; 5. Deathisabilit | 2020-02-14 |