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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27 STENT, VASCULAR, INTRACRANIAL

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MICROVENTION, INC. FRED 27 STENT, VASCULAR, INTRACRANIAL Back to Search Results
Model Number FRED3511-PMA
Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Thrombosis/Thrombus (4440)
Event Date 04/14/2021
Event Type  Injury  
Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device. Investigation is ongoing.
 
Event Description
It was reported that a fred 27 3. 5 x 17/11 was used to treat a pcom aneurysm. The patient had no significant tortuosity distal or proximal to the aneurysm. The distal measurement was 2. 8 mm and proximal was 3. 5 mm. The aneurysm was first coiled using a headway duo. The microcatheter was removed to insert the headway 27 to deploy a fred 27. The device was deployed at the terminus utilizing an unsheathing method and landed just distal to the ophthalmic artery. Flow through the device was visualized. The physician wanted to observe the contralateral side and strong flow across the acom was visualized, which warranted more observation on the device side. A dsa injection showed that the fred device was occluded at the proximal portion of the device with no flow distal. Intravenous integrilin was administered and flow was reported to be slow after 15 minutes. Strong flow across the acom filled the affected side and the anterior choroidal and pcom filled, but clot was still observed in the fred device. Patient is on integrilin drip and showed signs of weakness on contralateral side.
 
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Brand NameFRED 27
Type of DeviceSTENT, VASCULAR, INTRACRANIAL
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise
aliso viejo, CA 92656
7142478000
MDR Report Key11828561
MDR Text Key250861882
Report Number2032493-2021-00206
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRED3511-PMA
Device Lot Number20072255Q
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2020
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: 05/14/2021 Patient Sequence Number: 1
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