FDA Adverse Event
Death
Summary report: N
HYDROFILL 10-SYSTEM COIL (HFIL)
MDR report key: 4254837
·
Received November 11, 2014
Report
- Report Number
- 2032493-2014-00086
- Event Type
- Death
- Date Received
- November 11, 2014
- Date of Event
- October 9, 2014
- Report Date
- October 15, 2014
- Manufacturer
- MICROVENTION, INC.
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SAMPLE ANALYSIS: THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).
Description of Event or Problem · 1
COILING TREATMENT WAS CONDUCTED OF AN ACOM ANEURYSM MEASURING APPROXIMATELY 6.5MM. IT WAS REPORTED THAT DURING COIL PLACEMENT, THE LAST FEW LOOPS OF THE COIL COULDN'T BE DEPLOYED IN THE ANEURYSM. UPON REMOVAL, THE COIL DETACHED AND MIGRATED INTO THE PARENT ARTERY. A SNARE WAS USED TO RETRIEVE THE IMPLANT COIL SUCCESSFUL; HOWEVER, THE ANTERIOR CEREBRAL ARTERY (ACA) WAS DISSECTED. CONSEQUENTLY, THE VESSEL BECAME OCCLUDED AND THE PT HAS A STROKE. A STENT WAS DEPLOYED IN THE VESSEL TO HOLD THE ARTERY OPEN. IT WAS REPORTED THE PT WAS ON LIFE-SUPPORT POST PROCEDURE AND SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725925 | HYDROFILL 10-SYSTEM COIL (HFIL) | EMBOLIZATION COIL | HCG | MICROVENTION, INC. | 100515HFIL-V | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death |