MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL SR REG 10VTA; EMBOLIZATION COIL

Model Number	100830HCSR-R-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	12/13/2019
Type of Reportable Event	Malfunction
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 has not been returned to the manufacturer for evaluation.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that an embolization coil unexpectedly detached while partially deployed in the vessel.The coil could not be retracted back into the microcatheter.The pusher and microcatheter were removed; however, the implant coil was left in a more proximal segment of the vessel.There was no reported intervention or patient injury.The patient was reported to have left the hospital one day after the procedure is good condition.
Additional Manufacturer Narrative
Additional information (b5): treatment was performed on a dural fistulae.Device evaluation: the delivery pusher and microcatheter, a headway duo 167cm, were returned for evaluation.The pusher was found without the implant attached.The heater coil of the pusher does not display any signs of thermal detachment.The microcatheter tip is tapered is undamaged.The inner diameter is approximately 0.013", which is within specification.The microcatheter is pinched about 10.1 cm away from the distal tip.No implant was observed within the microcatheter via x-ray examination.No observable segment of the attachment monofilament could be found within the delivery pusher; the monofilament mostly likely broke at the attachment bond glue joint.Monofilament knots can be seen in the attachment bond glue joint.The investigation of the returned coil system found the implant to be separated from the pusher with no signs of activation from using a detachment controller.The investigation determined the separation of the implant is consistent with the implant experiencing tensile or retraction forces that exceeded the strength of the attachment monofilament.The microcatheter used in the procedure was returned and inspected; the tip appeared to be tapered, and a segment 10.1 cm from the distal tip was found to be pinched.The conditions on the microcatheter can cause increased friction on the coil during advancement and retraction, which could lead to the implant separation from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage to the microcatheter, but the damage is consistent with the device experiencing forces over specification.The implant was not returned for evaluation, so it could not be determined if it had any damage or other anomaly that would have caused or contributed to the reported event.

• Brand Name: MICROPLEX HELICAL SR REG 10VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9604641
• Report Number: 2032493-2020-00012
• Device Sequence Number: 19476252
• Product Code: HCG
• UDI-Device Identifier: 00816777020451
• UDI-Public: (01)00816777020451(11)180921(17)230831(10)1809215WL
• Combination Product (Y/N): N
• Initial Reporter Country: MO
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 100830HCSR-R-V
• Device Lot Number: 1809215WL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR