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

Model Number 100728HFRM-V-A2

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Stretched (1601)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 03/09/2021

Event Type  Death  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The investigation of the returned coil system confirmed the returned pusher is a non microvention product.The cause of the reported complaint cannot be determined as the microvention coil system was not returned.Four fluoroscopic images were provided.The first image shows a partially coiled aneurysm with a section of a coil extending proximally in the parent artery.The second and third images show a stretched section of the embolic coil extending into the parent artery.The fourth image is of limited quality and the aneurysm and embolic coils cannot be clearly seen.The first, second and third image confirmed the condition described in the complaint; however, the review of the images could not verify if the device shown was a microvention product or the product returned.Therefore, the reported complaint is considered non-verifiable.The instructions for use identifies coil misplacement and death as potential complications associated with use of the device.

Event Description

It was reported that during treatment of an aneurysm of the right internal carotid artery, an embolization coil stretched and detached during an attempt to re-frame it.A portion of the implant coil remained in the parent vessel.A stent was placed at the neck of the aneurysm to affix the stretched coil.The procedure was completed successfully with no concerns about blood flow.The patient's condition was reported to have deteriorated post-procedure and the patient passed away later.The official cause of death was intracranial hemorrhage.It was stated by the treating physician that the stretched coil did not cause or contribute to the patient's death.

Manufacturer Narrative

The distributor confirmed via email correspondence that the actual device is not available for return to the manufacturer for analysis.

• Brand Name: HYDROFRAME 10 ADVANCED
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11682815
• MDR Text Key: 245925451
• Report Number: 2032493-2021-00134
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023575
• UDI-Public: (01)00816777023575(11)180410(17)230331(10)1804105YB
• Combination Product (y/n): N
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 100728HFRM-V-A2
• Device Catalogue Number: 100728HFRM-V
• Device Lot Number: 1804105YB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 04/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 72 YR