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Model Number FRED4007-PMA
Device Problems Activation Failure (3270); Migration (4003)
Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
The device associated with this event was used during the same procedure referenced in mfr. Report # 2032493-2021-00192. 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 not returned to the manufacturer for evaluation. Intraprocedural images were provided. The provided images show the first fred stent foreshortening, thrombus formation with blockage of flow, use of pta and placement of a second fred stent and use of aggrastat to treat thrombus and reestablish flow. Without the returned and physical evaluation of the device, the investigation is unable to determine if a condition existed that caused or contributed to the reported event. The instructions for use identifies thrombosis and migration or misplacement as potential complications associated with use of the device.
Event Description
It was reported that a fred stent was implanted to treat a supraclinoid wide neck aneurysm. Immediate post implantation imaging showed good wall apposition, aneurysm status, and good perfusion. Three minutes later, a second angio run was performed and there was complete occlusion of fred with no distal perfusion and the device appeared to have thrombus affixed to it. After taking additional spot fluoro images, the device did not appear fully open, it had foreshortened, and it had also migrated proximally. Aggrastat ia was administered and percutaneous transluminal angioplasty (pta) was performed twice. A second fred stent was implanted since the first stent was no longer covering the aneurysm. Angio showed good wall apposition and reperfusion, but thrombus continued to form. Further medication was administered and pta was performed, but clot continued to form. The physician repeated pta multiple times and after waiting 15 minutes, patient had adequate flow. The physician decided to stop the case and see how the patient woke up. Post anesthesia, the patient woke up moving all extremities and was able to speak. This event refers to the first stent implanted.
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Brand NameFRED 27
Manufacturer (Section D)
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key11904851
MDR Text Key256279127
Report Number2032493-2021-00191
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED4007-PMA
Device Lot Number190507547M
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 Received05/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2019
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: 05/28/2021 Patient Sequence Number: 1