MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICA LVTA; EMBOLIZATION COIL

Model Number	100306HS-V
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	09/25/2018
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.The pusher was returned for analysis.The distal portion of the pusher was examined first.The strain relief did not show any signs of burn damage; however, the strain relief tip was noted to be damaged and folded.The solder joints on the heater coil were noted to be intact.The body coil of the pusher only had minor offset coils and no other notable damages.Along the length of the hypotube of pusher were a handful of bent areas.The resistance of the pusher was measured to be 41.7 ohms, and passed the 4-way v-grip connectivity test.The attachment monofilament in the pusher had a rebound of 0.0163".When fished out of the pusher, the tip of the attachment monofilament was noted to have a mushroom like shape with a head width of 0.004," which is the normal head measurement of mushroom tips.There were no other notable observations.Based on the available information and evaluation of the returned device, the complaint can be confirmed, as there was no evidence of a thermal detachment.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 clot formation and vascular thrombosis as potential complications associated with use of the device.
Event or Problem Description
It was reported that during repositioning of the embolization coil in an aneurysm, the coil stretched and then could not be withdrawn into the microcatheter.The coil was pushed forward until it was fully within the aneurysm and was then intentionally detached manually wtihout the controller.Follow-up angiography demonstrated thrombus at the neck of the aneurysm and in the vessel.Iv integrilin was administered as treatment.The patient was reported to be alright and had a good outcome.

• Brand Name: MICROPLEX HYPERSOFT HELICA LVTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8007117
• Report Number: 2032493-2018-00221
• Device Sequence Number: 13867728
• Product Code: HCG
• UDI-Device Identifier: 00816777024114
• UDI-Public: (01)00816777024114(11)180226(17)230131(10)1802265Y4
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: 100306HS-V
• Device Lot Number: 1802265Y4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/25/2018
• 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