MAUDE Adverse Event Report: MICROVENTION INC HYDROFRAME-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7110-0154
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported through a rage clinical study, on (b)(6) 2020, the patient received re-treatment for cerebral aneurysm that was originally embolization on (b)(6) 2018 with the use of seven coils.The patient required recoiling due to coil compaction.Diagnostic procedures were performed by using a balloon to assist the coiling.The recoiling results showed there was a good filling of the aneurysm with a coil mass and protection of the dome.After the procedure, the patient was awoken from anesthesia and was neurologically stable.The patient was transferred to the neurocritical care unit for close monitoring.The patient will remain on dual antiplatelet therapy for 4 to 6 weeks and after will be prescribed baby aspirin for life.
Additional Manufacturer Narrative
A search for non-conformances associated with this lot number did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device coils were was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided; however, operative notes were received.The alleged product issue could not be confirmed at this time.However, the investigation is ongoing.Upon completion, of the investigation, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information received 9 may 2023 that included the part number, and it is added in section d3.Investigation results were completed on 1 june 2023.Procedure note medical review: a detailed procedure note medical review has been performed.Data review indicates that the patient received retreatment for coil compaction within an aneurysm performed on (b)(6) 2018.On (b)(6) 2020, the patient required recoiling due to coil compaction.Data review indicates that the following coils were deployed hydrosoft 3-d 3 mm x 6 cm.6.Hydrosoft 3-d 3 mm x 6 cm.7.Hydrosoft 3-d 3 mm x 4 cm.8.Hydrosoft 3-d 3 mm x 6 cm.9.Hydrosoft 3-d 2.5 mm x 6 cms successfully.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: based on a review of the last 2 years of complaint data, and at the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Ifu review (additional information can be found in the ifu): potential complications potential complications include, but are not limited to: hematoma at the site of entry, vessel perforation, aneurysm rupture, parent artery occlusion, incomplete aneurysm filling, emboli, hemorrhage, ischemia, vasospasm, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.Cases of chemical aseptic meningitis, edema, hydrocephalus and/or headaches have been associated with the use of embolization coils in the treatment of large and giant aneurysms.The physician should be aware of these complications and instruct patients when indicated.Appropriate patient management should be considered.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• 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: 16883091
• Report Number: 2032493-2023-00711
• Device Sequence Number: 5717899
• Product Code: KRD
• UDI-Device Identifier: 00816777025357
• UDI-Public: (01)00816777025357(11)170728(17)220630(10)1707281W9
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 7110-0154
• Device Catalogue Number: 7110-0154
• Device Lot Number: 1707121W8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/06/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female