MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT ADVANCED; EMBOLIZATION COIL

Model Number	8510-0308
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
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 device has been returned to the manufacturer.The investigation is underway.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 during retraction of an embolization coil, the coil stretched and then detached, leaving the distal implant in the aneurysm and a length of coil tail in the parent artery.A gooseneck snare was used to retrieve the entire detached coil segment from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
The device was returned with the pusher, introducer, implant, snare, and microcatheter for analysis.The pusher was returned inside the introducer.The introducer was found to be in good condition and without damage.The snare was returned with the coil still attached.The coil was found to be deformed and had a stretched tail at the proximal end.The coil was also found to be broken at the proximal end.The microcatheter was found to have multiple damaged (>5 smashed and/or kinked) locations.There were additional sections of the microcatheter that showed signs of strain via necking.The distal end of the catheter was found to be in good condition.The proximal end of the pusher was found to be in good condition and without damage.There was one bent section on the hypotube on the pusher.The distal end of the pusher was in good condition, with the exception of a fold in the strain relief.The heater coil was undisturbed and did not show signs of attempted detachment.The implant was found to be attached to the pusher.The implant was broken just distal of the proximal tie knot.Based on the investigation findings and available information, the reported complaint is confirmed, as the implant was found to be detached just distal of the proximal tie knot location.The coil had been separated into two lengths.The returned microcatheter was found to be damaged, but it is unknown as to when the microcatheter was damaged.It was also not noted whether friction was experienced during retraction in the microcatheter.The displayed damage to the returned implant system is consistent with an implant that became stuck in a damaged microcatheter.The root cause of the reported event cannot be determined based on the physical evaluation of the returned device due to the severity of the damage; it appears the coil separated due to excessive force during the initial retraction of the device, and not due to a normal thermal detachment.This force was likely induced due the coil becoming stuck at the damaged section of the microcatheter and retraction force being applied during the procedure.The excessive damage to the coil is likely due to the removal with the snaring device.

• Brand Name: HYPERSOFT ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8382534
• Report Number: 2032493-2019-00038
• Device Sequence Number: 1651674
• Product Code: HCG
• UDI-Device Identifier: 00816777020925
• UDI-Public: (01)00816777020925(11)180919(17)230831(10)1809191WH
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050954
• 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,Followup
• Report Date (Section B): 01/30/2019

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 8510-0308
• Device Lot Number: 1809191WH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 03/07/2019
• 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