MAUDE Adverse Event Report: MICROVENTION, INC. HELICAL-10-AV; ARTIFICIAL EMBOLIZATION DEVICE

Model Number	100515HCSR-R-V-A1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during aneurysm embolization procedure, when the coil was deployed in the aneurysm resistance encountered and only half the coil deployed.The coil unintentionally detached in the microcatheter when it was being removed from the patient.The coil along with the microcatheter were successfully removed and procedure completed successfully.There was no report of harm or injury to the patient.
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 to the manufacturer for analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Additional Manufacturer Narrative
Additional information: h6, h10 (summary device evaluation).Summary device evaluation: the microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The implant was the only component returned for evaluation.The investigation of the returned implant found the loops to be deformed at proximal.The stretch resistance monofilament was cut, and the implant regained shape.The shape loss appears to be the result of an increased tension in the monofilament - this issue is tracked by quality and manufacturing.The coil pusher was not returned for evaluation.Without the returned and evaluation of the pusher, the investigation is unable to determine the mode of separation (i.E.Unintentional vs normal detachment using a detachment controller); however, the implant was found with a tensile break mono shape at the proximal marker band which is consistent with the device experiencing excessive force that exceeded the 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 damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: HELICAL-10-AV
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13405191
• Report Number: 2032493-2022-00036
• Device Sequence Number: 4935957
• Product Code: HCG
• UDI-Device Identifier: 00812636027531
• UDI-Public: (01)00812636027531(11)170627(17)220531(10)17062753A
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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 Expiration Date: 05/31/2022
• Device Model Number: 100515HCSR-R-V-A1
• Device Catalogue Number: 100515HCSR-R-V
• Device Lot Number: 17062753A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 62 KG