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

Model Number 7110-0510-A2

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

Patient Problems Intracranial Hemorrhage (1891); Ruptured Aneurysm (4436)

Event Date 11/16/2021

Event Type  malfunction  

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 device was implanted in the patient and not returned to the manufacturer for investigation.The alleged event and product issue could not be confirmed.

Event Description

As reported through the rage study, a patient with a history of hypertension and hypothyroidism presented with a one day history of headaches and confusion.The patient was found to have diffuse subarachnoid hemorrhage with an anterior communicating artery aneurysm on cta.The patient underwent endovascular, balloon assisted coil embolization of an anterior communicating artery aneurysm with excellent obliteration of aneurysm, consistent with raymond roy grade 1.The procedure was complicated by intraprocedural rupture.Reportedly, following insertion of a hydroframe 5mm x 10cm embolization coil implant, the coil was noted to be partially protruding through the aneurysm wall into the subarachnoid space.A transform balloon was inflated and a second coil was rapidly placed without evidence of extravasation on the following injection.The last coil implant (see mdr 2032493-2021-00503) partially herniated into the anterior communicating artery, but without evidence of surrounding thrombosis or flow limitation.Dyna ct showed evidence of new hemorrhage, however, with mild hydrocephalus necessitating evd insertion.

• Brand Name: HYDROFRAME 10 ADVANCED
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13015933
• MDR Text Key: 285240905
• Report Number: 2032493-2021-00502
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023674
• UDI-Public: (01)00816777023674(11)180928(17)230831(10)1809285PF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: 7110-0510-A2
• Device Lot Number: 1809285PF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2018
• 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): Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male