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Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhagic Stroke (4417); Ruptured Aneurysm (4436)
Event Type  Death  
Manufacturer Narrative
The lot numbers were not provided; therefore, a search for production-related ncrs could not be performed. The devices were implanted in the patient and procedural or post procedural images were not provided; therefore, the alleged event cannot be confirmed. The instructions for use (ifu) identifies hemorrhage, including intracranial hemorrhage, rupture or perforation of the aneurysm, and death as potential complications associated with use of the device.
Event Description
As reported through the article titled, "flow redirection endoluminal device (fred) with or without adjunctive coiling in treatment of very large and giant cerebral aneurysms," published in clinical neuroradiology and reviewed by company on august 20, 2021: two (2) patients developed hemorrhagic complications from aneurysm rupture, which resulted in death. With the first patient, a paraophthalmic sacculofusiform aneurysm without intraluminal thrombosis, measuring 23 × 22 × 22mm was treated with a fred stent alone. Intra-arterial vaso ct showed the fred covering the aneurysmal segment with good wall apposition. Immediate postprocedural cerebral dsa revealed intra-aneurysmal contrast stagnation. Patient received 100mg acetylsalicylic acid/75mg plavix per day postoperatively. The aneurysm ruptured 1 week after the operation and the patient later passed away. Several attempts to obtain additional case information were unsuccessful. The second patient had a sacculofusiform left supraophthalmic ica aneurysm without intraluminal thrombosis that was treated with a fred stent alone. There was no immediate stasis. The patient received ticagrelor 90 mg twice a day/asa 100 mg once a day postoperatively. No follow-up imaging was performed. Hemorrhage occurred in the 3rd month after treatment and the patient later passed away. Several attempts to obtain additional case information were unsuccessful.
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Brand NameFRED
Manufacturer (Section D)
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key12492164
MDR Text Key272104179
Report Number2032493-2021-00383
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 foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received08/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/17/2021 Patient Sequence Number: 1