MAUDE Adverse Event Report: MICROVENTION INC. HYDROFRAME 10 FRAMING COIL; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number 7110-0715

Device Problems Unraveled Material (1664); Activation Problem (4042)

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

Event Date 01/08/2019

Event Type  malfunction  

Event Description

During stent-assisted coil embolization of aneurysm for large ophthalmic segment, left ica aneurysm, a complication was experienced with attempt to place second coil.During attempted deployment, the second neuro coil did not deploy, it then unraveled when the physician attempted to pull it back out, making it difficult to remove from the aneurysm.The physician was eventually able to snare the coil and bring it out of the aneurysm and out of the body.No loose coils were left in the body.However, microcatheter access to the aneurysm was lost during this maneuver and therefore no further coils were placed.A lvis blue stent was placed and established flow-diverting properties.Per the physician, the aneurysm may thrombose on its own.Physician to follow-up with patient in 6 months.

• Brand Name: HYDROFRAME 10 FRAMING COIL
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; tustin CA 92780
• MDR Report Key: 8343727
• MDR Text Key: 137122033
• Report Number: MW5084122
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 7110-0715
• Device Lot Number: 161213F1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 66