MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number 8410-0310-A2

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Difficult To Position (1467); Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

The coil remains implanted and the pusher wire was discarded at the user facility; therefore, a product evaluation could not be performed.The root cause is unknown.

Event Description

It was reported that stent-assisted coiling was performed on a previously coiled anterior cerebral artery (aca) aneurysm.After implantation of several coils, the hypersoft 3d coil was placed; however, part of the coil was noted to be looping into the ipsilateral a2 artery.During an attempt to slowly remove the coil, the coil detached after approximately 10mm of the coil had been withdrawn.The pusher wire was removed and the jailed catheter with the coil inside was pulled back into the proximal aca.The coil loops that were noticed in the ipsilateral a2 were gone; however, the detached coil that was not jailed by the stent traveled to the middle cerebral artery (mca).A stent was implanted in the mca to trap the detached coil segment.There was no reported patient injury.The patient is reported to be doing well.

• Brand Name: HYPERSOFT 3D ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: sandra valencia ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6324601
• MDR Text Key: 67208935
• Report Number: 2032493-2017-00037
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777025159
• UDI-Public: (01)00816777025159(11)161220(17)211130(10)161220W5
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/29/2021
• Device Model Number: 8410-0310-A2
• Device Lot Number: 161220W5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ECHELON 10 MICROCATHETER; LVIS JR 2.5 X 13 STENT; LVIS JR 2.5 X 23 STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR