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

Model Number	181652CS-V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
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 was not returned for analysis.The root cause is unknown.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during placement of an embolization coil, the implant coil detached prematurely without use of the controller.The coil was retrieved with difficulty with a microsnare.There was no reported adverse patient sequela.
Additional Manufacturer Narrative
Corrected data: (d10)(h3) the pusher, introducer, and part of the implant were returned for analysis.The microcatheter was not returned for analysis.Review of the unit found the implant to be separated from the pusher.The implant was intact at the distal end but was stretched proximally.The implant was found to be broken in the middle with the markerband missing.The proximal end of the implant was not returned.It was noted that a snare was used to remove the implant from the patient.It is unknown as to when the implant separated into multiple pieces and if it resulted from the procedure or snare operation.The introducer was found to be in good condition and without damage.The pusher was found to be in good condition with only minor damage at the distal end.The strain relief contained minor folding at the distal end.It is unknown if this was the result of tensile or compressive forces.No signs of thermal detachment were noted.The tether was found to have been separated at the attachment location.It is presumed to reside with the missing proximal end of the implant.The implant coil was found to be detached from the pusher.The implant had sustained severe damage, limiting the scale of the investigation and root cause analysis.The nature of the stretching is consistent with an implant that was subject to forces that exceed its intended specification.The microcatheter was not returned, preventing analysis of any contributing conditions.

• Brand Name: MICROPLEX COSMOS
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8902408
• Report Number: 2032493-2019-00191
• Device Sequence Number: 216316
• Product Code: KRD
• UDI-Device Identifier: 00810170014147
• UDI-Public: (01)00810170014147(11)160511(17)210531(10)16051114
• Combination Product (Y/N): N
• Initial Reporter Country: SY
• PMA/510(K) Number: K102365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 181652CS-V
• Device Catalogue Number: 181652CS-V
• Device Lot Number: 16051114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/24/2019
• 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: 62 YR
• Patient Weight: 85