MAUDE Adverse Event Report: MICROVENTION, INC. HP8 AZUR HYDROPACK 18; PERIPHERAL EMBOLIZATION COIL

Model Number	45-880035
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Items returned: an operative report was requested and our request was denied.- 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/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.The physician should be aware of these complications and instruct patients when indicated.Appropriate patient management should be considered.Warnings and precautions: ¿ this device is intended for single use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death.Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.¿ 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 repositioning is necessary, take special care to retract the coil under fluoroscopy in a one-to-one motion with the delivery pusher.If the coil does not move in a one-to-one motion with the delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly break.Gently remove and discard the entire device.¿ due to the delicate nature of the coils, the tortuous vascular pathways that lead to certain lesions, and the varying morphologies of the vasculature, a coil may occasionally stretch while being maneuvered.Stretching is a precursor to potential coil breakage and migration.Introduction and deployment of the azur system 22.Seat the distal tip of the introducer sheath at the distal end of the microcatheter hub and close the rhv lightly around the introducer sheath to secure the rhv to the introducer.Do not over-tighten the rhv around the introducer sheath.Excessive tightening could damage the device.23.Push the coil into the lumen of the microcatheter.Use caution to avoid catching the coil on the junction between the introducer sheath and the hub of the microcatheter.Initiate timing using a stopwatch or timer at the moment the device enters the microcatheter.Detachment must occur within the specified reposition time.24.Push the azur system through the microcatheter until the proximal end of the delivery pusher meets the proximal end of the introducer sheath.Loosen the rhv.Retract the introducer sheath just out of the rhv.Close the rhv around the delivery pusher.Slide the introducer sheath completely off of the delivery pusher.Use care not to kink the delivery system.To prevent premature hydration of the azur system, ensure that there is flow from the saline flush.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.28.Complete the deployment and any repositioning so that the coil will be detached within the reposition time specified in table 1.After the specified time, the swelling of the hydrophilic polymer may prevent passage through the microcatheter and damage the coil.If the coil cannot be properly positioned and detached within the specified time, simultaneously remove the device and the microcatheter.
Event or Problem Description
It was reported that the interventionalist attempted to embolize an abnormal branch of the thyrocervical artery in a pediatric patient.This artery measured about 2mm diameter with 30+mm of length.A glide catheter and microcatheter were being used.An anchor coil was successfully placed, followed by an attempt to place a hydoropack coil.The coil did not pack well, leading the interventionalist and team to take multiple attempts at getting it to pack and place properly in the artery.During these prolonged efforts (5-8 repositions over a minute or two), the coil prematurely detached from the pusher wire while a long segment of coil was still contained inside the catheters.The catheter-retained segment of coil extended all the way back to the iliac artery segment, near to the femoral artery access site.As the coil would not pack into the target artery, it could not be safely pushed out of the microcatheter, thus the team underwent attempts to remove the coil.With the distal segment of the coil securely fixed in the coil pack in the target artery, the microcatheter was removed and aspirated on the jb1 to externalize the coil outside the femoral sheath.The coil was grabbed and at this point began to pull, yet the coil began to unravel into its filar component at this point and the team was unsuccessful at removing the entire coil.What followed was a prolonged attempt to remove the coil using small vascular forceps of a couple different varieties and requiring two additional vascular access points.During these attempts, right brachial access was obtained and the coil filar mid-segment was captured and externalized outside the right arm with 3f, 120cm forceps.At this point, the filar was broken, and the segment of coil/filar that extended from the arm to the femoral artery was successfully removed from the femoral sheath.At this point, the procedure had extended 2-4 hours beyond the initial plan, the distal coil remained in the target artery / coil pack and the target artery was shown to be occluded, while what remained of the coil filar was extending down the arm and was contained inside the brachial sheath.The decision was made to remove the sheaths and end the procedure, with the terminal end of the coil filar extending through the right subclavian, axillary, and brachial arteries, exiting the artery, and terminating in the soft tissue of the upper arm.The patient did awaken from anesthesia after the procedure and return to their neurological and physical/motor baseline in the acute setting.The patient is doing well.

• Brand Name: HP8 AZUR HYDROPACK 18
• Common Device Name: PERIPHERAL EMBOLIZATION COIL
• 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: 19215240
• Report Number: 2032493-2024-00337
• Device Sequence Number: 15514304
• Product Code: KRD
• UDI-Device Identifier: 00842429118061
• UDI-Public: (01)00842429118061(11)240116(17)281231(10)0000497499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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 Model Number: 45-880035
• Device Lot Number: 0000497499
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2024
• 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: Hospitalization
• Patient Sex: Unknown