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

Model Number 7110-0405

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

Patient Problem Neuropathy (1983)

Event Date 09/10/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The coil was implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.The device was used during the same procedure as was reported in mfr report# 2032493-2018-00238 and mfr report# 2032493-2018-00239.The instructions for use (ifu) identifies neurological deficits as potential complications associated with use of the device.

Event Description

It was reported that an uneventful balloon assisted coiling procedure for a ruptured right posterior communicating artery aneurysm was performed on a patient that presented with sudden headache and reduced conscious level, and subarachnoid hemorrhage.Post procedure, the patient woke up with ipsilateral 3rd nerve palsy.The condition did not improve with a short course of steroids, and the patient underwent neurosurgical nerve decompression two (2) days later, which was believed to be a result of an immediate mass effect of the coiled aneurysm on the 3rd nerve.

• Brand Name: HYDROFRAME 10 ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 8049356
• MDR Text Key: 126502904
• Report Number: 2032493-2018-00237
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023650
• UDI-Public: (01)00816777023650(11)171122(17)221031(10)1711221W8
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 7110-0405
• Device Lot Number: 1711221W8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2017
• 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): Required Intervention
• Patient Age: 70 YR