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 2018-12-07 for YASARGIL TI PERM STD-CLIPSTRG-CVD7.4MM FT823T manufactured by Aesculap Ag.
[130037469]
(b)(4). Manufacturing site evaluation: no product was returned. Batch nor serial number provided. A review of the device quality and manufacturing history records was not possible. Conclusion- failure is possible related to insufficient usage. Rationale - it is very important to ensure that the occlusion of the aneurysm or vessel is achieved and that the clip sits correctly on the aneurysm neck during and after the implantation and sits tight on the blood vessel. According to the ifu, the instructions must be used to avoid damage or a failure of the implant.
Patient Sequence No: 1, Text Type: N, H10
[130037470]
It was reported that there was postoperative slippage of a yasargil aneurysm clip. The initial surgery and implantation of the clip occurred on (b)(6) 2009. It was noted that another manufacturer's clip had also been used near the yasargil clip. On (b)(6) 2009, the slip-out occurred. Limited information was provided, but additional data has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00576 |
| MDR Report Key | 8142146 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-07 |
| Date of Event | 2009-06-19 |
| Date Facility Aware | 2018-11-28 |
| Date Mfgr Received | 2018-11-14 |
| Date Added to Maude | 2018-12-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGIL TI PERM STD-CLIPSTRG-CVD7.4MM |
| Generic Name | CEREBRO VASCULAR CLIPS |
| Product Code | HCH |
| Date Received | 2018-12-07 |
| Model Number | FT823T |
| Catalog Number | FT823T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-07 |