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

Model Number	100204HS-V
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional 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.A portion of the pusher and stent retriever were returned for analysis.The pusher was noted to be damaged throughout the body coil portion, where the distal portion was completely stretched and tangled.The proximal half of the pusher was missing, with the breakage point of the body coil tip having an elongated appearance.The body coil, proximal to the attachment bond was bent, wavy, and stretched.The attachment bond area of the pusher was still intact, with the tie knot of the attachment monofilament present.Distal to the attachment bond area, the lead wires of the pusher were kinked and pulled out of the body coil of the pusher.The heater coil of the pusher was bent, and the strain relief tip folded.The attachment monofilament tip was in the body coil of the pusher, where the tip of the monofilament was taken out and observed to be stretched.There were no other notable observations.Based on the available information and evaluation of the returned device, the complaint can be confirmed.The root cause cannot be determined; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.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 the embolization coil did not detach.During the attempt to remove the coil, it stretched and detached.The coil was removed successfully with a snare device.There was no reported patient injury as a result of the issue.The patient was reported to be fine.

• Brand Name: MICROPLEX HYPERSOFT HELICAL VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7954391
• Report Number: 2032493-2018-00216
• Device Sequence Number: 1531800
• Product Code: HCG
• UDI-Device Identifier: 00816777020604
• UDI-Public: (01)00816777020604(11)170421(17)220331(10)170421W2
• Combination Product (Y/N): N
• Initial Reporter Country: CU
• PMA/510(K) Number: K131948
• 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
• Report Date (Section B): 09/10/2018

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 100204HS-V
• Device Lot Number: 170421W2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/10/2018
• 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: 69 YR
• Patient Weight: 65