MAUDE Adverse Event Report: MICROVENTION, INC AZUR-35 DETACHABLE HYDRO; PERIPHERAL

Model Number	45-451230
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during placement of an embolization coil within a renal vein for pelvic congestion, the implant coil prematurely detached from the delivery pusher.The coil was pulled and stretched and unraveled.The coil and stretched portion was salvaged and coiled into the appropriate vessel.An additional coil was placed behind the original coil to secure the stretched coil.No patient harm or injury was reported.
Additional Manufacturer Narrative
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention will issue a supplemental report.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Additional Manufacturer Narrative
A follow-up report is being submitted to make correction from: fei-based, to: cfn based.Fei was selected in error.Our 1-3 acknowledgments from our initial submission are attached.
Event or Problem Description
It was reported that during placement of an embolization coil within a renal vein for pelvic congestion, the implant coil prematurely detached from the delivery pusher.The coil was pulled and stretched and unraveled.The coil and stretched portion was salvaged and coiled into the appropriate vessel.An additional coil was placed behind the original coil to secure the stretched coil.No patient harm or injury was reported.
Additional Manufacturer Narrative
A follow-up report is being submitted to make correction from: fei-based, to: cfn based.Fei was selected in error on our initial report.The patient identifier in section a1 has been changed to: (b)(6).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/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.Warnings and precautions: do not advance the delivery pusher with excessive force.Determine the cause of any unusual resistance, remove the azur system, and check for damage.Advance and retract the azur system slowly and smoothly.Remove the entire azur system if excessive friction is noted.If excessive friction is noted with a second azur system, check the microcatheter for damage or kinking.If a coil must be retrieved from the vasculature after detachment, do not attempt to withdraw the coil with a retrieval device, such as a snare, into the delivery catheter.This could damage the coil and result in device separation.Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously.Introduction and deployment of the azur system 27.Under fluoroscopic guidance, slowly advance the coil out the tip of the microcatheter.Continue to advance the coil into the lesion until optimal deployment is achieved.Reposition if necessary.If the coil size is not suitable, remove and replace with another device.If undesirable movement of the coil is observed under fluoroscopy following placement and prior to detachment, remove the coil and replace with another more appropriately sized coil.Movement of the coil may indicate that the coil could migrate once it is detached.Do not rotate the delivery pusher during or after delivery of the coil into the vasculature.Rotating the delivery pusher may result in a stretched coil or premature detachment of the coil from the delivery pusher, which could result in coil migration.Angiographic assessment should also be performed prior to detachment to ensure that the coil mass is not protruding into undesired vasculature.Conclusion: the physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: AZUR-35 DETACHABLE HYDRO
• Common Device Name: PERIPHERAL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142748000
• MDR Report Key: 15724220
• Report Number: 0002032493-2022-00505
• Device Sequence Number: 16862134
• Product Code: KRD
• UDI-Device Identifier: 00810170015007
• UDI-Public: (01)00810170015007(11)211124(17)261031(10)0000128717
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 11/27/2022

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 Model Number: 45-451230
• Device Catalogue Number: 45-451230
• Device Lot Number: 128717
• 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: 10/24/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 12/06/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/27/2022; 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female