MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT-AV; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	8510-0102-A1
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: the eye artery segment aneurysm was 3.8mm*2.7mm, and the first coil 3*6 was filled, followed by 2*3, 1.5*3 and finally, the closing coil 1*2.After the closing coil was delivered into the aneurysm, the coil detached.When the pusher was pulled back, it was found that the coil did not detach normally, and many attempts to detach afterwards failed.When the coil was removed, it was found that the coil detached in the microcatheter.The embolization was completed after the microcatheter was re-used and a new coil 1*2 was used for replacement.Patient is normal.
Additional Manufacturer Narrative
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.The device was stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: the eye artery segment aneurysm was 3.8mm*2.7mm, and the first coil 3*6 was filled, followed by 2*3, 1.5*3 and finally, the closing coil 1*2.After the closing coil was delivered into the aneurysm, the coil detached.When the pusher was pulled back, it was found that the coil did not detach normally, and many attempts to detach afterwards failed.When the coil was removed, it was found that the coil detached in the microcatheter.The embolization was completed after the microcatheter was re-used and a new coil 1*2 was used for replacement.Patient is normal.
Additional Manufacturer Narrative
Items returned for evaluation: pusher; implant; introducer, items not returned for evaluation: shrink lock; dispenser hoop; microcatheter; v-grip.The visual analysis of the returned device found that the pusher was returned without the implant attached and the pusher heater coil showed signs of activation using a detachment controller.The implant was returned stretched, damaged, and separated from the pusher.The device was tested with a continuity test using an in-house v-grip controller, and all tries gave out green lights.The pusher resistance was measured and found to be within specification, and proximal resistance was within specification.The investigation found the pusher's monofilament with a mushroom profile, which indicates that the implant did detach from thermal activation.The investigation of the returned coil system found the implant stretched, damaged, and separated from the pusher.The unit passed continuity and resistance testing.The pusher heater coil was found to have visible burn marks; furthermore, the investigation found the pusher¿s monofilament profiled a mushroom shape, which indicates the implant detached from thermal activation.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.However, as the microcatheter and detachment controller used in the procedure were not returned for evaluation, the investigation could not determine if a condition existed that would have caused or contributed to the reported complaint and therefore, this complaint is considered non-verifiable.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 over specification.

• Brand Name: HYPERSOFT-AV
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 20008250
• Report Number: 2032493-2024-00618
• Device Sequence Number: 4343529
• Product Code: KRD
• UDI-Device Identifier: 00812636022284
• UDI-Public: (01)00812636022284(11)240502(17)290430(10)0000591486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8510-0102-A1
• Device Lot Number: 0000591486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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
• Patient Sex: Unknown