MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-01 for WEB SLS 27 SINGLE LAYER FG15090-001 manufactured by Sequent Medical, Inc.
[143805272]
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 returned to the manufacturer for evaluation. The investigation is underway.
Patient Sequence No: 1, Text Type: N, H10
[143805273]
It was reported that after delivery into the aneurysm, the web was protruding into the carotid artery. The web was retracted to achieve better positioning in the aneurysm; however, during the attempt, the delivery wire detached from the web. The carotid artery was almost 90% occluded by the proximal segment of the web. A snare device was used to capture the device marker and retrieve the web successfully. There was no reported patient injury. The patient was reported to be stable and was discharged the day after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2019-00113 |
| MDR Report Key | 8571727 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2018-08-14 |
| Date Added to Maude | 2019-05-01 |
| 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 SLS 27 SINGLE LAYER |
| Generic Name | WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM |
| Product Code | OPR |
| Date Received | 2019-05-01 |
| Returned To Mfg | 2019-04-26 |
| Model Number | FG15090-001 |
| Lot Number | 18081414 |
| 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. Required No Informationntervention | 2019-05-01 |