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 2020-01-02 for LVIS JR 2.5X23 172020-LVISJ manufactured by Microvention, Inc..
[173442408]
A search for non-conformance 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 stent was implanted and the delivery system was not returned for evaluation. The root cause cannot be determined. The instructions for use (ifu) identifies vascular occlusion, vessel stenosis, and neurologic insufficiencies including stroke and death as potential complications associated with the use of the device.
Patient Sequence No: 1, Text Type: N, H10
[173442409]
It was reported that stent-assisted coil embolization was performed. After access through tortuous anatomy, the lvis jr. Stent was successfully deployed from the left a1 to the right a2 and imaging confirmed full stent expansion. Three coils were then successfully placed at the treatment site without incident. Final procedure images demonstrated a clot in the middle of the stent. A bolus of integrilin was administered and tpa was delivered directly to the clot. As the clot was starting to dissolve, a spontaneous bleed was discovered at the p-com where no interventional work was done or devices had been placed. Integrilin and heparin were reversed, without success. Multiple devices were then used to stop bleeding, also without success. It was reported that the patient had insufficient blood flow to the left hemisphere of the brain at that point. The patient is reported to have expired. The exact date and cause of the patient's death is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2020-00001 |
| MDR Report Key | 9541992 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2019-12-04 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2019-12-03 |
| Date Added to Maude | 2020-01-02 |
| 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 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LVIS JR 2.5X23 |
| Generic Name | INTRALUMINAL SUPPORT DEVICE |
| Product Code | QCA |
| Date Received | 2020-01-02 |
| Model Number | 172020-LVISJ |
| Lot Number | 19010954J |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC. |
| Manufacturer Address | 35 ENTERPRISE DRIVE ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2020-01-02 |