MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 FRAMING COIL VTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100833HFRM-V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2020
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 was not returned to the manufacturer for evaluation.The root cause cannot be determined.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 deployment of an embolization coil, the coil prematurely detached and got stuck in the microcatheter.The coil was removed together with the microcatheter.There was no reported patient injury.
Additional Manufacturer Narrative
The pusher and implant were returned for analysis.The introducer, microcatheter, and packaging were not returned.Investigation into the returned device found the device to be severely damaged.The pusher was broken into two pieces at the pet transition.The proximal end of the pusher contained numerous bent locations.The implant, pusher body coil, and lead wires were entangled in a mass.The body coil was stretched and the lead wires were pulled from beneath the coil.The implant was stretched throughout its length with the exception of the distal loop.The heater coil was found to be burnt, displaying evidence of thermal detachment.Based on the investigation findings and available information, the root cause of the complaint cannot be determined.The device was severely damaged, preventing a root cause analysis into the reported complaint.The physical evaluation of the device could not determine if the damages occurred leading up to the reported event, and which occurred after, but the damage is consistent with the device experiencing forces over specification.The severity of the damage prevented replication testing from being performed.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9729408
• Report Number: 2032493-2020-00036
• Device Sequence Number: 19367966
• Product Code: HCG
• UDI-Device Identifier: 00816777023599
• UDI-Public: (01)00816777023599(11)190312(17)240229(10)1903125PF
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090357
• 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): 01/20/2020

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: 02/29/2024
• Device Model Number: 100833HFRM-V
• Device Catalogue Number: 100833HFRM-V
• Device Lot Number: 1903125PF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement 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