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

Model Number 7110-0410

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage, Subarachnoid (1893); Rupture (2208)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided.A review of the approved device history record could not be performed.The device was not returned for evaluation; therefore, a product analysis could not be performed.The root cause is unknown the instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with use of the device.

Event Description

It was reported that balloon-assisted coil embolization was performed on a patient with a ruptured right pcomm artery aneurysm with associated subarachnoid hemorrhage.The occlusion balloon was placed at the ostium of the aneurysm.After placement of the first coil in the aneurysm, an angiogram demonstrated extravasation of contrast into the subarachnoid space.The balloon was inflated and coiling was resumed.No additional extravasation was observed afterward.There was no reported adverse patient sequela as a result.The patient was enrolled in the rage clinical trial and will be closely monitored per clinical trial protocol.

Manufacturer Narrative

Additional information: the lot number was provided, allowing for an exact match for the model number and a search of the production records; 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.

• Brand Name: HYDROFRAME 10 ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8834383
• MDR Text Key: 152464787
• Report Number: 2032493-2019-00180
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 7110-0410
• Device Lot Number: 1811135WF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR