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

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.

• Brand Name: FRED
• 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: 12492164
• MDR Text Key: 272104179
• Report Number: 2032493-2021-00383
• Device Sequence Number: 1
• Product Code: OUT
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/17/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Death