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

Model Number 100308HS-V-A2

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problems Infarction, Cerebral (1771); Paresis (1998); Thrombus (2101)

Event Date 11/28/2017

Event Type  Injury  

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 was has not been returned for evaluation.The instructions for use (ifu) identifies neurological deficits, infarction, and thrombus as potential complications associated with use of the device.

Event Description

It was reported that balloon-assisted coil embolization was performed on a middle cerebral artery bifurcation aneurysm.After placement of the coil, the balloon was deflated and the coil prolapsed into the parent artery.During the attempt to resheath and remove the coil, a lot of resistance was encountered.After two additional attempts were made, the coil was withdrawn entirely into the microcatheter; however, by this time, some thrombus was identified at the neck of the aneurysm.No more coils were deployed.The clot was resolved after administering 6 ml of aggramed, and the procedure was stopped.The patient was reported to have slight hemiparesis.The day after the procedure, a ct revealed a small infarct near the temporal lobe.The patient's condition improved two (2) days later and she was discharged.The patient is reported to have fully recovered.

Manufacturer Narrative

The device was returned with introducer and dispenser coil.The implant was attached to the pusher, with the attachment tether on the marker band still in good tension.The implant coil was noted to be stretched, and the stretch resistance inside the implant broke at the tie knot.The black pet on the pet transition, from the hypotube to the body coil section, appeared broken.There were many kinks noted on the pusher, especially in the middle of the hypotube near the warning mark section, and two (2) on the body coil section.Attempts were made to advance the pusher into the introducer to check for the ease of advancement/retraction; however, the pusher could not be advanced due to the presence of too many kinks.There were a number of issues reported as follows: the last loop of the coil remaining in the vessel; resistance trying to re-sheath; thrombus observed at the neck of the aneurysm during the procedure; and a small infarct the day after the procedure.Heavy damage to the pusher/implant coil was found in the analysis from apparent pulling against resistance, but the other reported factors of the case were unverifiable.The cause of the reported resistance was not identified by the returned device analysis, due to the heavy damage found on the device.

• Brand Name: MICROPLEX HYPERSOFT HELICAL VTA
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 7158377
• MDR Text Key: 96608344
• Report Number: 2032493-2018-00001
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777020680
• UDI-Public: (01)00816777020680(11)170601(17)220531(10)17060153H
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 100308HS-V-A2
• Device Lot Number: 17060153H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 55