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U.S. Department of Health and Human Services

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

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MICROVENTION, INC. FRED 27 FLOW DIVERTER Back to Search Results
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. ".
 
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Brand NameFRED 27
Type of DeviceFLOW 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 Key13014897
MDR Text Key285240149
Report Number2032493-2021-00497
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED3511-PMA
Device Lot Number20110968X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
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