| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | WEB LOW PROFILE SL | WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM | SEQUENT MEDICAL, INC | OPR | FGA25060-030 | FGA25060-030 | 19030423 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-04-24 | 0 | 1. D; 2. H; 3. L; 4. R |
Patient 1
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 1
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 THE WEB WAS RETRACTED AND REMOVED TOGETHER WITH THE VIA MICROCATHETER.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.