MAUDE Adverse Event Report: MICROVENTION INC. FRED X27; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FREDX5026
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	08/24/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
No product(s) were returned for evaluation, but five images were provided by the customer for evaluation.One image shows the fred in the left supraclinoid ica; however, the detail is not sufficient to comment on the opening of the braid.The proximal and distal markers appear open on the image.Another image shows a red arrow to what is reported as a left a1 dissection (long, thin filling defect); however, the review determined that the area marked by the red arrow is consistent with the shadow of the microcatheter, as it is seen crossing the ica terminus and continuing along the lateral wall of the supraclinoid ica.The cause for the non-opening of the proximal fred is not seen in these images; furthermore, no images were provided that show the hemorrhage itself on ct or mri, or the cause and location of the perforation that caused the hemorrhage.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The instructions for use (ifu) identifies intrcranial hemorrhage and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an ica aneurysm treatment, the fredx distal portion was placed at ica terminus and was opened at the opposed vessel wall, but the proximal portion did not open fully past a curve in the patient's neurovascular anatomy.The physician re-sheathed and re-deployed the fredx multiple times to try to open the proximal end fully.After complete deployment, the physician made several attempts to open the proximal end by using a microcatheter and guidewire, but he was unable to gain access to the fredx.The physician then chose to enter the contralateral vasculature through the acom to access the fredx with a sl-10 microcatheter, and he was able to open the proximal portion of the fredx with ample wall apposition.The physician did a final run of the procedure and did not notice anything.At some point, the patient was brought back to the angiosuite and the physician noticed a vessel bleed on the contralateral vasculature that was not noticed during the final run of the procedure.The patient passed away due to bleeding on the contralateral side in the acom/a1 region.It was reported that the vessel bleed was due to the physician's maneuver accessing the distal portion of the fredx through the contralateral vasculature and was not in relation to the fredx device.

• Brand Name: FRED X27
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15471992
• Report Number: 2032493-2022-00372
• Device Sequence Number: 2892764
• Product Code: OUT
• UDI-Device Identifier: 00842429114469
• UDI-Public: (01)00842429114469(11)211214(17)241130(10)0000132273
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: FREDX5026
• Device Catalogue Number: FREDX5026
• Device Lot Number: 0000132273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY 27 MICROCATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Female