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 2019-03-28 for WEB LOW PROFILE SL FGA25050-030 manufactured by Sequent Medical, Inc.
[140269337]
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 remains implanted; therefore, a product analysis could not be performed. The root cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
[140269338]
It was reported that treatment was being performed for an unruptured middle cerebral artery aneurysm. Access to the treatment site and positioning of the web in the aneurysm were accomplished without incident. After placement of the web, there was difficulty maintaining the patient's airway, and it appeared that the left lung had collapsed. The web was detached, and follow-up angiography confirmed proper placement. No contrast extravasation was noted at that time. The procedure was paused for several minutes to manage the patient's airway. Upon resuming the procedure, angiography demonstrated contrast extravasation from the aneurysm. A scepter occlusion balloon was placed and inflated at the neck of the aneurysm for approximately 3 minutes, occluding the aneurysm. During deflation of the balloon, it appeared that the web shifted position, occluding two mca m2 divisions; therefore, an atlas stent was implanted across the neck of the aneurysm to secure the web in the aneurysm to allow the mca branches to remain patent. The procedure was completed with satisfactory placement of the web and no evidence of active extravasation. Post-procedure mra was performed immediately after the procedure, which demonstrated small focal deficits in the frontal lobe and blood in the subarachnoid space. The patient was moved to the icu, awoke, was extubated, and was able to move all limbs. For two days following the procedure, patient status follow-ups from the physician indicated the patient was recovering and still in the icu. The peri-procedural hemorrhage was determined to be a procedure-related incident from the anesthesia related complications. Post-procedure, the patient had a full neurological recovery almost to baseline. Prior to discharge, the patient expired from acute liver and kidney failure due to her previous medical condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2019-00069 |
| MDR Report Key | 8462772 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-28 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-28 |
| 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 | CHARLOTTE AYALA |
| Manufacturer Street | 35 ENTERPRISE |
| 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 | 2019-03-28 |
| Model Number | FGA25050-030 |
| Catalog Number | FGA25050-030 |
| Lot Number | 18122102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Other; 4. Required No Informationntervention | 2019-03-28 |