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

Model Number VFC061030-V

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Paresis (1998)

Event Date 03/22/2019

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 has been returned to the manufacturer.The investigation is underway.The instructions for use (ifu) identifies premature coil detachment as a known potential complication associated with use of the device.

Event Description

It was reported that during treatment of a basilar tip aneurysm, the 2nd embolization coil was approximately 50% inside the aneurysm when an attempt was made to remove and replace the coil; however, the coil detached in the microcatheter as it was being withdrawn.The coil was successfully removed with a stent retriever.Slight thrombus formation was identified along the coil upon removal from the patient.The patient's current condition was described as "weak left sided arm paresis.".

Event Description

Additional information received from the customer on (b)(6) 2019: there was only one immediate attempt to push the coil in the aneurysm; however, it was clear immediately that this would not work.The snare was inserted within 5 min.After trying to catch the coil for about 8 min, the snare was retraced and the stent retriever inserted.After approximately 10 minutes, the coil could be fixed in the guiding catheter and, and completely extracted.In the control angiogram, no vessel occlusion was observed; however, the small vessels that were affected due to the mri after the procedure, cannot be detected in an angiogram.As we did not observe a thrombus after retraction, no further medication was given at this point.The patient was under aspirin and plavix as a 2nd stent (to the one that was inside since 2 years) might have been necessary in this procedure.At the end the second stent was not needed.At the end of the procedure, there was thrombus formation at the aneurysm base, and after 2.5 hrs after the coil retraction, 20 mg reopro wwas given over the guiding catheter.The aneurysm is completely occluded now.The patient recovered from the slight arm and leg paresis, and is at a rehabilitation clinic.The paresis is likely to be related to the retraction maneuver, as it cannot be related to the occlusion of the basilar tip aneurysm.As we did not see any thrombus in the control angiogram, we cannot be sure that this is indeed the case.Thrombus formation is also possible in every coiling procedure, even without any obvious complication.

Manufacturer Narrative

Additional information received from the customer on (b)(6) 2019 is notated in event.The pusher, implant, and microcatheter were returned for analysis.The pusher was kinked.The implant coil was not attached, and the monofilament was broken inside the pusher.The implant coil was stretched in the middle and was damaged, kinked, and stretched at the tie knot location based upon the investigation analysis and available information, the reported complaint of a detached coil is confirmed.The body coil and implant were damaged, kinked, and stretched.This type of condition can be produced or occur when the unit is subject to excessive force during handling, if the microcatheter and implant coil were in a tortuous position, wrong manipulation, or incorrect catheter position during the retraction process.The root cause of the complaint could not be determined.

• Brand Name: MICROPLEX VFC FILL COIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8533090
• MDR Text Key: 142542096
• Report Number: 2032493-2019-00096
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170016233
• UDI-Public: (01)00810170016233(11)180123(17)221231(10)1801231RC
• Combination Product (y/n): N
• PMA/PMN Number: K111451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

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
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: VFC061030-V
• Device Lot Number: 1801231RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention