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

Model Number	100208HC-S-V
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
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 has not been returned to the manufacturer for evaluation.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 an embolization implant coil unexpectedly detached in the patient.There was no reported patient injury or intervention.The patient's outcome is currently reported to be "great.".
Additional Manufacturer Narrative
Additional information / corrected data: (h10) clarifying information received confirmed that the returned device was the device associated with this event.Correction (d10) correction (h3) correction (h6): method, results the device was returned with the implant coil attached to the pusher.No burn damages were observed on the heater coil area.The implant was tangled and was stretch-damaged starting from the proximal marker band and extending to the mid portion of the implant.The distal ball of the implant was within dimensional specification.The pusher attachment bond area was not damaged and was within dimensional specification.The reported complaint is unconfirmed.The investigation of the returned coil system found the implant to be attached to the pusher with no signs of activation using a detachment controller.The implant was received severely stretched, but it was attached to 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.No other notable conditions were found with the returned device.
Additional Manufacturer Narrative
Additional information: (b1).Additional information: (b2).Additional information: (b5) additional information was provided, which indicated that a stent was implanted as treatment for the reported detached coil segment in the vessel.Corrected data: (h1).A device was returned to the manufacturer on 1/15/20; however, it was not the device associated with the reported event, as the implant coil was still attached to the pusher.The detached implant coil remains in the patient and the pusher was not returned for evaluation; therefore, the root cause could not be determined.

• Brand Name: MICROPLEX HELICAL SOFT
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9599360
• Report Number: 2032493-2020-00008
• Device Sequence Number: 2525691
• Product Code: HCG
• UDI-Device Identifier: 00810170010057
• UDI-Public: (01)00810170010057(11)170727(17)220630(10)1707271R2
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2019

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 Expiration Date: 06/30/2022
• Device Model Number: 100208HC-S-V
• Device Catalogue Number: 100208HC-S-V
• Device Lot Number: 1707271R2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 03/10/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/14/2020; 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention