MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number FRED3511-PMA

Device Problem Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 11/18/2021

Event Type  Injury  

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 returned to the manufacturer for analysis; however, investigation is not complete and still ongoing.The instructions for use (ifu) identifies migration or misplacement, and hemorrhage, including intracranial hemorrhage (ich), subarachnoid hemorrhage (sah) as potential complications associated with use of the device.

Event Description

It was reported that the fred 27 stent was used in an aneurysm embolization procedure.Upon deployment, the sent appeared normal and in the correct position.Post deployment angiogram showed the stent migrated distally from the vertebral artery into the v-b junction and no longer covering the aneurysm.The decision was made to place a second fred device to cover the aneurysm.A "j'd" syncro soft wire was attempted to pass through the stent to facilitate the second fred device.The moment the wire touched the initial fred stent device, the stent migrated further distally into the mid-basilar segment.Attempts to retrieve the stent using multiple techniques including snares were unsuccessful.After several hours the physicians decided to make another attempt the next morning and wake the patient up to assess neurological status.The patient was put on an integrillin drip, brilinta, double dose asa and full heparinization.The following morning additional attempts were made and the fred device was retrieved with the "loop and snare technique." patient suffered a minor subarachnoid hemorrhage (sah).Current patient condition described as "patient is neurologically intact with no focal deficits.".

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 returned to the manufacturer for analysis; however, investigation is not complete and still ongoing.The instructions for use (ifu) identifies migration or misplacement, and hemorrhage, including intracranial hemorrhage (ich), subarachnoid hemorrhage (sah) as potential complications associated with use of the device.

Event Description

It was reported that the fred 27 stent was used in an aneurysm embolization procedure.Upon deployment, the sent appeared normal and in the correct position.Post deployment angiogram showed the stent migrated distally from the vertebral artery into the v-b junction and no longer covering the aneurysm.The decision was made to place a second fred device to cover the aneurysm.A "j'd" syncro soft wire was attempted to pass through the stent to facilitate the second fred device.The moment the wire touched the initial fred stent device, the stent migrated further distally into the mid-basilar segment.Attempts to retrieve the stent using multiple techniques including snares were unsuccessful.After several hours the physicians decided to make another attempt the next morning and wake the patient up to assess neurological status.The patient was put on an integrilin drip, brilinta, double dose asa and full heparinization.The following morning additional attempts were made and the fred device was retrieved with the "loop and snare technique." patient suffered a minor subarachnoid hemorrhage (sah).Current patient condition described as "patient is neurologically intact with no focal deficits.".

Manufacturer Narrative

Additional information: h3, h6, h10 (summary device evaluation).Summary of device evaluation: analysis was conducted on the dicom images that were provided and based on the images, it appeared that the proximal end of fred was under significant tension during deployment along the inner curvature of v4 segment of vertebral artery.This may have resulted in the proximal end of the device to get stretched.It was also evident that the proximal end of fred had poor wall apposition with proximal neck of aneurysm during deployment and post deployment.Non tapered location of implant deployment and lack of vessel curvature/tortuosity reduces device anchorage at implantation site.The stent was returned damage, and due to the damage, the stent was unable to be loaded for further evaluation.The portion where the stent diameter can be verified is within specification.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• 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: 13014897
• MDR Text Key: 285240149
• Report Number: 2032493-2021-00497
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106662
• UDI-Public: (01)00842429106662(11)201109(17)231031(10)20110968X
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• 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,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: FRED3511-PMA
• Device Lot Number: 20110968X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female