MAUDE Adverse Event Report: MICROVENTION, INC. HP8 AZUR HYDROPACK 18; VASCULAR EMBOLIZATION DEVICE

Model Number	45-880050
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to the manufacturer and the investigation is ongoing.Upon completion of the investigation, a supplemental mdr report will be submitted.
Event or Problem Description
It was reported that during an aortic collateral artery embolization multiple coils were used prior to the concerned coil being placed.The 50cm coil was placed through a 2.8f microcatheter, which was advanced through a 4f intermediate catheter.The intermediate catheter was in the ostium of a collateral vessel off the abdominal aorta.After a difficult advancement of the concerned coil into the target vessel, the coil detachment was attempted using a detachment controller.After two deployment cycles to detach the coil, the physician thought the coil was detached; however, the coil came back a little.The physician advanced the coil back into the vessel where most of the 50cm was coiled into.When repositioning the coil it detached on its own and a tale of the coil was in the aorta.Attempt to tuck the end into the vessel with the catheter tip and a wire was unsuccessful.The physician then used a 10 gooseneck snare to remove the coil.While removing the coil through the catheter it started to string out.The physician slowly pulled on the coil/wire and successfully removed the whole coil.Multiple other coils were used in this procedure in multiple different locations.The case finished successfully and the patient left the room in stable condition.
Additional Manufacturer Narrative
Investigation conclusion: the investigation found the implant to be damaged, stretched at the middle section, separated from the pusher and entangled, which is consistent with the condition described in the reported event.The implant's monofilament was found to have a mushroom shape at the proximal end and a tensile break at the distal tip, indicating that the implant experienced a partial/delayed detachment.This condition is consistent with a partial thermal activation resulting in the implant to not separate until the device experienced forces that exceeded the tensile strength of the monofilament, causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant damage, but the damage is consistent with the device experiencing forces exceeding its yield strength.A search for non-conformance's 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.

• Brand Name: HP8 AZUR HYDROPACK 18
• Common Device Name: VASCULAR 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: 23538342
• Report Number: 2032493-2025-90647
• Device Sequence Number: 9962041
• Product Code: KRD
• UDI-Device Identifier: 00842429118078
• UDI-Public: (01)00842429118078(11)250520(17)300430(10)0001103838
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 45-880050
• Device Lot Number: 0001103838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.8F PROGREAT MICROCATHETER (TERUMO MEDICAL).; 4F LIMA INTERMEDIATE CATHETER (MEDTRONIC).; GOOSENECK SNARE DEVICE (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 19 KG