MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100620H2HS-V
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Serious Injury
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 implant, pusher and microcatheter were returned for analysis.The introducer was not returned for analysis.No notable conditions or damage were found on the returned microcatheter.Investigation into the returned components found the implant to be separated from the pusher.The strain relief was found in good condition.Additionally, the gold connector of the pusher was found kinked, as well as the hypotube.Further inspection on the implant found that there was deformation and also stretched coils.The pusher was also tested for resistance and continuity.The results of the pusher met the specifications and passed the testing.The heater coil contained no signs of activation using a detachment controller.The separation of the implant is consistent with the device experiencing tensile forces that exceeded the strength of the monofilament.The physical evaluation of the returned components could not determine the circumstances that led up to the separation, but was likely the result of the coil becoming stuck during repositioning.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that during placement of an embolization coil in the aneurysm, the coil was withdrawn back into the microcatheter three (3) times for repositioning and then it unexpectedly detached.The detached coil segment was retrieved with a solitaire stent without incident.There was no reported patient injury.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9913732
• Report Number: 2032493-2020-00080
• Device Sequence Number: 3130935
• Product Code: HCG
• UDI-Device Identifier: 00816777021649
• UDI-Public: (01)00816777021649(11)190906(17)240831(10)1909065WR
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: 08/31/2024
• Device Model Number: 100620H2HS-V
• Device Catalogue Number: 100620H2HS-V
• Device Lot Number: 1909065WR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 04/01/2020
• 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