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

Model Number 7110-0206

Device Problems Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.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 not returned to the manufacturer for evaluation; therefore, a product analysis could not be performed.The root cause cannot be determined.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

A medsun report # (b)(4) was received and reported that a patient with a right medial temporal intra-cranial hemorrhage with associated right posterior communicating artery aneurysm underwent diagnostic femoral cerebral angiogram with primary coil embolization of the right posterior communicating artery aneurysm.Four (4) coils were deployed.Following this, a hyrdrosoft 3d (2mm x 6cm) coil was deplyed.Per the operative report, increased resistance was met upon deployment of this coil, and upon respositioning the coil within the aneurysm sac, the coil was identified to have stretched and detached on its own.In the process to adjust, it was noted the coil tail herniated into the internal carotid artery.The coil was eventually snared and removed.There was no reported patient injury.The event date was noted at (b)(6) 2019; however, the exact date was not provided.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 8616696
• MDR Text Key: 145276466
• Report Number: 2032493-2019-00144
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777025395
• UDI-Public: (01)00816777025395(11)181112(17)231031(10)1811125P6
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 7110-0206
• Device Catalogue Number: 7110-0206
• Device Lot Number: 1811125P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 38