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

Model Number	100206HS-V-A2
Medical Device Problem Codes	Detachment Of Device Component (1104); Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned; therefore, a product analysis could not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that after placement of the final embolization coil in an a-com aneurysm, the coil did not detach.During removal, the coil unexpectedly detached.The coil was successfully retrieved with a snare device.There was no reported patient injury.The patient is reported to be doing well.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 6960387
• Report Number: 2032493-2017-00264
• Device Sequence Number: 795123
• Product Code: HCG
• UDI-Device Identifier: 00816777020628
• UDI-Public: (01)00816777020628(11)170419(17)220331(10)170419W2
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 100206HS-V-A2
• Device Lot Number: 170419W2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/18/2017
• 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