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

Model Number 182263CS-V

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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.An investigation was conducted on the returned device; the pusher and implant were found to be inside of the microcatheter.The pusher was returned inserted into the hub of the microcatheter in the incorrect direction and was stuck at the gold connector transition.The pusher was removed and reviewed for damage.Lead wire separation was noted through the proximal end of the pusher.The rest of the pusher, including the heater coil, was found to be in good condition and without damage.The implant was within the body of the microcatheter and was separated from the pusher.No signs of damage were noted on the returned catheter.There was dried blood and biomaterial in the microcatheter.The microcatheter was excised to expose the proximal end of the implant.Prior to extraction, it was noted that the implant was stretched at the proximal end.Pulling on the implant via the marker band, the implant was able to be removed.Friction was noted upon removal and lessened as areas with biomaterial exited the microcatheter.The monofilament was examined but was found to have an unidentifiable profile.However, the heater coil did not appear to have been activated using a detachment controller.The monofilament was examined and found to have an unidentifiable detachment profile.However, with the implant stretched and the heater coil having no signs of activation from a detachment controller, the investigation determined the separation of the implant is consistent with the coil experiencing tensile or retraction forces that exceeded the strength of the attachment monofilament.Besides the dried biomaterial within the lumen, no notable conditions were found on the returned microcatheter.Advancement testing could not be performed due to the damages on the returned components.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.

Event Description

It was reported that during treatment for a ruptured carotid cavernous aneurysm, the embolization coil was difficult to advance in the microcatheter and during removal, the implant coil detached in the microcatheter.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.

• Brand Name: MICROPLEX COSMOS
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9760281
• MDR Text Key: 191444366
• Report Number: 2032493-2020-00042
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K090891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Model Number: 182263CS-V
• Device Lot Number: 15061614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 67