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

Model Number	8510-0308-A1
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2024
Type of Reportable Event	Malfunction
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 returned for evaluation.The investigation is currently ongoing.
Event or Problem Description
It was reported that during treatment of an aneurysm of the middle cerebral artery, an embolization coil implant appeared larger than the actual specification during placement in the aneurysm.The coil was removed and a new coil was selected for placement.The angiographic effect was satisfactory, the procedure was successfully concluded.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher.-implant.-dispenser hoop.Items not returned for evaluation: -introducer.-shrink lock.-microcatheter.The visual analysis of the returned items found the implant loops deformed, and the pusher bodycoil offset at the distal end.The implant od was measured was found to be out of specification (spec= 3mm +/- 0.5mm).During the investigation, after the monofilament was cut, the implant's 1st proximal loop regained its shape and was within specification; however, the other implant loops remained out of specification.The investigation of the returned coil system found the pusher bodycoil offset at the distal end, and the implant loops deformed.Furthermore, the implant outer diameter was found to measure over specification due to the loop deformity, which is consistent with the alleged product issue.The stretch resistance monofilament was cut, and the implant regained shape at the first proximal loop, but the rest of the implant loops were still deformed.The implant loop deformity is consistent with increased tension in the monofilament.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
It was reported that during treatment of an aneurysm of the middle cerebral artery, an embolization coil implant appeared larger than the actual specification during placement in the aneurysm.The coil was removed and a new coil was selected for placement.The angiographic effect was satisfactory, the procedure was successfully concluded.

• Brand Name: HYPERSOFT ADVANCED
• 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: 19745891
• Report Number: 2032493-2024-00540
• Device Sequence Number: 12414052
• Product Code: KRD
• UDI-Device Identifier: 00812636022475
• UDI-Public: 00812636022475
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 8510-0308-A1
• Device Catalogue Number: 8510-0308
• Device Lot Number: 0000199606
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/10/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2022
• 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