MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 FRAMING COIL VTA; VASCULAR EMBOLIZATION DEVICE

Model Number 100612HFRM-V-A2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem Stroke/CVA (1770)

Event Date 05/16/2021

Event Type  malfunction  

Event Description

It was reported that during an embolization treatment of a right media aneurysm on (b)(6) 2021 four hydroframe-10 av coils were deployed without incident.On (b)(6) 2021 imaging revealed some small micro-infarcts.The patient was reported in good condition without permanent neurological damage.No secondary intervention was taken and no sequelae was reported.

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 was thus not available for evaluation.However, procedure imaging was provided for review.There are 3 subtracted dsa coned-down images of a right ica angiogram.One shows an approximately 7 mm right mca bifurcation aneurysm.The other two are obliques that show the final result after coiling the aneurysm.There are some loops of coils protruding slightly into the parent artery; the imaging does not display evidence of a clot.The last image is a set of mri axial images at the mid-level of the brain demonstrating infarcts in the right basal ganglia and caudate nucleus, as well as multiple small infarcts in the distal mca territory.Since the physical device was not able to be evaluated, the investigation could not determine if a condition existed that would have caused or contributed to the reported event.

Manufacturer Narrative

H11: corrections: h6: medical device problem code.H6: remove code 2993 from the initial report.

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Type of Device: VASCULAR 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: 13741184
• MDR Text Key: 289083105
• Report Number: 2032493-2022-00083
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00816777023544
• UDI-Public: (01)00816777023544(11)200608(17)250531(10)2006085WF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100612HFRM-V-A2
• Device Catalogue Number: 100612HFRM-V
• Device Lot Number: 2006085WF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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