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

Model Number XFRED4513-MVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/19/2021

Event Type  Injury  

Event Description

It was reported that while treating with a fred x, the patient had a thromboembolic reaction on the proximal and distal end of the stent.Aggrastat was administered.The patient was fully preloaded.There was no report of harm or injury to the patient, who was doing fine.

Manufacturer Narrative

At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u.S.The complaint is being reported now as based on this product meeting similar product criteria.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 is not available for return to the manufacturer for analysis, and procedure images were not provide.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies in-stent thrombosis as potential complications associated with use of the device.

Manufacturer Narrative

At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u.S.The complaint is being reported now as based on this product meeting similar product criteria.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 is not available for return to the manufacturer for analysis, and procedure images were not provide.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies in-stent thrombosis as potential complications associated with use of the device.

Event Description

It was reported that while treating with a fred x, the patient had a thromboembolic reaction on the proximal and distal end of the stent.Aggrastat was administered.The patient was fully preloaded.There was no report of harm or injury to the patient, who was doing fine.

Manufacturer Narrative

Additional information was provided via email.The site of treatment was the posterior communicating artery.Seven pairs of images were provided for investigation.Pair #1: lateral subtracted and non-subtracted ica dsa pre-stenting (not labeled right or left): there is an ophthalmic segment aneurysm measuring about 8x10 mm.The parent artery pre and post aneurysm measures 4.16 mm and 3.57 mm.A fred is seen in a non-opacified artery, likely the contralateral ica; there is a large mass of coils, presumably in the contralateral aneurysm.Pair #2: lateral subtracted and non-subtracted ica dsa post-stenting with fred 4.5 x 20: the fred is well positioned from the carotid siphon, across the neck of the aneurysm, and anchored distally in the supraclinoid ica, below the anterior choroidal artery.There are small filling defects at the distal and proximal ends of the braided part of the stent, representing early clot formation.Pair #3: lateral subtracted and non-subtracted ica dsa post-tirofiban bolus: the clot at the distal end of the stent is essentially resolved, but there has been slight increase in the clot at the proximal end.Pair #4: lateral non-subtracted ica dsa x2 post-pta and fred 4.5 x 25: the proximal first fred has migrated slightly distally and is compressed at the level of the neck of the aneurysm.The second fred begins inside the distal part of the first fred and finishes in the carotid siphon, proximal to the beginning of the first fred.There is no clot.Pair #5: lateral subtracted and non-subtracted ica dsa post- post-pta and fred 4.5 x 25: please refer to the fred positions described above.There may be subtle clot at the proximal braid of fred #2.Pair #6: ap whole head subtracted, and non-subtracted right ica dsas labeled "switch to ticagrelor": normal appearing angiogram except for the right sided aneurysm still filling.Only an early to mid-arterial phase is supplied and stasis in the aneurysm cannot be evaluated.Pair#7: 2 axial mras obtained at the level of the aneurysm and adjacent ica, dated (b)(6) 2021 and (b)(6) 2021: the aneurysm is thrombosed (no signal) and the ica is patent.The aneurysm has not decreased in size.The physical device was not returned or evaluated as part of this investigation, so it cannot be determined if a condition existed that would have caused or contributed to the reported event.

• Brand Name: FRED X27
• 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: 13064852
• MDR Text Key: 285241933
• Report Number: 2032493-2021-00519
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429107546
• UDI-Public: (01)00842429107546(11)200828(17)210731(10)20082811Q
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: XFRED4513-MVE
• Device Lot Number: 20082811Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2020
• 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): Required Intervention
• Patient Sex: Female