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 2020-03-20 for HYDROFILL 10 ADVANCED 7310-0720 manufactured by Microvention, Inc..
[188847402]
A search for non-conformances 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 device was returned to the manufacturer for evaluation. The investigation is underway. The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Patient Sequence No: 1, Text Type: N, H10
[188847423]
It was reported that stent-assisted coiling was performed for a large aneurysm in a tortuous vessel. After several coils had been placed, the embolization coil could not fit entirely in the aneurysm. After 6-7 minutes of coil retraction and advancement attempts, 1:1 movement was lost. During attempted coil removal, the coil stretched. A gooseneck snare was used to assist with coil removal and the coil detached. The implant coil was left in place with some coil extending outside the aneurysm and the patient was put on dual antiplatelet/asa therapy post-procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2020-00069 |
| MDR Report Key | 9862431 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-10-01 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROFILL 10 ADVANCED |
| Generic Name | NEUROVASCULAR EMBOLIZATION DEVICE |
| Product Code | HCG |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-10 |
| Model Number | 7310-0720 |
| Lot Number | 1910011W5 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC. |
| Manufacturer Address | 35 ENTERPRISE ALISO VIEJO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |