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

Model Number	181859CS-V-A1-CN
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that after half of the embolization coil had been placed in the aneurysm, the delivery pusher could no longer advance.During the attempt to retract the coil, the coil unexpectedly detached, leaving the distal end of the coil in the aneurysm and the proximal portion of the coil in the vessel.A guidewire was used to capture the coil and remove it from the patient.There was no reported patient injury.The patient is reported to be fine.
Additional Manufacturer Narrative
The pusher and introducer were returned for analysis, with a very long implant fully detached from the pusher.The detached implant had evidence of the marker band and distal ball.The implant coil appeared kinked at the proximal end.The distal section of the body coil near the heater section, was stretched to check the presence of any broken implant monofilament/attachment tether.Although the attachment section had sufficient adhesive to retain the monofilament tie knot in place, the attachment tether appears to have come undone from that section.The rest of the pusher was advanced through the introducer, without experiencing any friction.No other damages were noteed on the pusher or the introducer tubing.Based upon the investigation findings and available information, the complaint could not be confirmed; there was no evidence that the coil broke into separate pieces.The pusher was noted to be separated from the coil; however, the adhesive that held the tie knot was adequate.The root cause could not be determined; however, the device exhibited evidence that it was subjected to forces that exceeded its strength specification, evident by the stretched and separated monofilament.

• Brand Name: MICROPLEX COSMOS18-AV
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7051523
• Report Number: 2032493-2017-00294
• Device Sequence Number: 16458683
• 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): 10/23/2017

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: 11/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: 50 YR
• Patient Weight: 55