MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COSMOS18-AV; EMBOLIZATION COIL

Model Number	181859CS-V-A1-CN
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2016
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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during an embolization treatment, the coil did not advance in the microcatheter.The coil unexpectedly detached in the blood vessel as it was being withdrawn.A snare device was used to retrieve the detached coil.There was no reported patient injury.The patient is reported to be fine.
Additional Manufacturer Narrative
The device was returned for evaluation.The implant came detached from the pusher.The heater coil was compressed.The pet was removed and the monofilament exposed.The monofilament has striations confirming a tensile stretch.Based on the investigation and provided information, the complaint of a detached implant can be confirmed.The specific root cause of this complaint is unknown, although the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: MICROPLEX COSMOS18-AV
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6775627
• Report Number: 2032493-2017-00193
• Device Sequence Number: 137342
• Product Code: HCG
• UDI-Device Identifier: 00812636026190
• UDI-Public: (01)00812636026190(11)161018(17)210930(10)161018W7
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090891
• 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,Followup
• Report Date (Section B): 07/12/2017

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: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: 181859CS-V-A1-CN
• Device Lot Number: 161018W7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 09/11/2017
• 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
• Patient Age: 68 YR
• Patient Weight: 60