MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; COILS

Model Number	7110-0410-A2
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	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.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.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.
Event or Problem Description
As reported through the rage clinical study, coil compaction was observed 16 months post treatment.Retreatment was performed to treat the coil compaction.Resolved without sequelae on (b)(6) 2023.No patient harm or injury was reported.
Additional Manufacturer Narrative
Items returned: n/a.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.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.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.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: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.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.Procedure note medical review: procedure note medical review for complaint: (b)(4).A detailed medical review for complaint: (b)(4) has been performed.Data review indicates patient was treated for subarachnoid hemorrhage with a left a1, a2 junction aneurysm.Patient treated for cerebral aneurysm which was ruptured.Post coiling control angiogram demonstrated greater than 95 percent occlusion of the ruptured aneurysm.Data reflects successful endovascular treatment for ruptured aneurysm utilizing primary coiling.Additional data review indicates that the patient presented for planned re-coiling embolization procedure for previously treated aneurysm.Procedure note medical review conclusion for complaint: (b)(4).A detailed procedure note medical review has been completed for complaint: (b)(4).Data review indicated that the planned re-coiling procure was completed, no device malfunction was reported.No patient injury or harm was reported.Successful endovascular sent assisted coil embolization was reported with patient reported as awake and neurologically stable post procedure.
Event or Problem Description
See h10.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terry callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16882626
• Report Number: 2032493-2023-00709
• Device Sequence Number: 12608849
• Product Code: KRD
• UDI-Device Identifier: 00816777025234
• UDI-Public: (01)00816777025234(11)210715(17)260630(10)2107135WF
• 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: 2021
• 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,Followup
• Report Date (Section B): 04/20/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: 7110-0410-A2
• Device Lot Number: 2107135WF
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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: Unknown