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

Device Problems Electrical /Electronic Property Problem (1198); Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

Event Type  Injury  

Event Description

This was a critically ill patient with a ruptured brain aneurysm.We attempted endovascular coiling of the aneurysm using detachable microvention hydroframe coils.After successful positioning of the coil within the aneurysm, the coil would not detach despite trying several coil detachers.We ultimately had to remove the coil from the ruptured aneurysm, an extremely dangerous maneuver that runs the risk of tearing the aneurysm or stretching the coil.We were able to successfully coil the aneurysm using another coil brand.This is one report, but this exact issue has happened at least five times at our center within the last 1.5 years.We have shared our concerns with microvention and they have identified several instances of a manufacturing defect resulting in an electrical short that prevents delivering sufficient current to detach the coil.At least three of these have been reported to microvention.Microvention assured us that this issue had been resolved, but we have had two events since this assurance.After the first of these two instances, microvention swapped out our entire coil inventory to their most newly manufactured coils which are supposed to be free of this defect, but they evidently are not.These detachment problems are unique to microvention coils.Based on our center's experience, we believe that 1-2% of coils have this defect.With that level of defect rate, plus the fact that multiple (3-10) coils are typically needed in every patient, these coils in their current state are unsafe to use in humans.Fda safety report id # (b)(4).

• Brand Name: MICROVENTION HYDROFRAME 10
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.
• MDR Report Key: 11365147
• MDR Text Key: 233466220
• Report Number: MW5099554
• Device Sequence Number: 4
• Product Code: HCG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR