MAUDE Adverse Event Report: MICROVENTION, INC MICROPLEX HELICAL REGULAR; EMBOLIZATION COIL

Model Number	100730HC-R-V
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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 pusher and implant were returned for analysis.The introducer, dispenser hoop, and microcatheter were not returned.Inspection of the pusher found two sections of lead wire separation.Both sections were at the proximal end and measured 11" and 8" respectively.Aside from the lead wire separation, the pusher was found to be in good condition and without damage.The resistance of the pusher was found to be within specification at 40.7 ohms, indicating no damage to the lead wire/solder joints.The implant was found to still be attached to the pusher.No issues were observed at the markerband/heater coil interface.The implant, however, was broken in two pieces.The filament and filar itself were broken.The implant also contained numerous kinks, bends, and stretched locations.Stretching was noted at the break location.Based on the investigation findings and available information, the reported complaint is confirmed; the implant was found to be broken in two pieces as noted in the complaint.The root cause of the break is unknown.The issue is not related to a manufacturing defect.Though the source of the damage on the implant is unknown, the damage is consistent with an implant that was under forces that exceed its specification.The microcatheter and introducer are considered integral components in the root cause analysis and were not returned.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during embolization of an aneurysm of the left middle cerebral artery, an embolization coil encountered friction during advancement in the microcatheter.During removal of the device from the microcatheter, the implant coil stretched and broke.The device was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.

• Brand Name: MICROPLEX HELICAL REGULAR
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8881259
• Report Number: 2032493-2019-00188
• Device Sequence Number: 18895731
• Product Code: HCG
• UDI-Device Identifier: 00810170010200
• UDI-Public: (01)00810170010200(11)180725(17)230630(10)1807255V3
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 100730HC-R-V
• Device Catalogue Number: 100730HC-R-V
• Device Lot Number: 1807255V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR