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

Model Number	100506HS-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The lot number was provided.A lot history trending review was performed and there were no similar complaints for this lot number.The device was has not yet been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during treatment of an aneurysm, the embolization coil was advanced without resistance through a microcatheter.As the coil was being positioned and manipulated inside the aneurysm under fluoroscopy, the coil unexpectedly detached without use of the controller.A few seconds later, the coil migrated outside the aneurysm with the force of the patient's blood flow.An attempt was made to retrieve the coil with a vascular snare device; however, it was unsuccessful.The following day, another attempt was made to retrieve the coil with an alligator retrieval device; however, when the coil was captured, it broke into two (2) parts.One part migrated to the humeral artery and was surgically removed.
Additional Manufacturer Narrative
The implant was returned; however, the pusher system was not returned for analysis.The implant coil appears stretched and entangled with human tissue.Based on the available information and evaluation of the implant, the root cause for the reported complaint cannot be determined, as the pusher was not returned for evaluation.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6752962
• Report Number: 2032493-2017-00184
• Device Sequence Number: 13887028
• Product Code: HCG
• UDI-Device Identifier: 00812636021034
• UDI-Public: (01)00812636021034(11)160425(17)210425(10)16042511
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K132952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: 06/30/2018
• Device Model Number: 100506HS-V
• Device Lot Number: 130628H8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/29/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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