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

Model Number	100408HFRM-V-A2
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
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 received by the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during placement of the second coil in an aneurysm, the previously placed coil was dislocated and stretched, and the second coil could not advance into the aneurysm.During the attempt to withdraw the second coil, the coil detached in the microcatheter.Part of the detached coil remains in the aneurysm and part of the coil is in the parent vessel.No additional intervention was performed and there was no reported patient injury.The patient woke up immediately after the procedure and had no abnormal symptoms.The patient's current condition is reported to be "normal.".
Additional Manufacturer Narrative
Only the delivery pusher was returned for evaluation, which was found to meet specifications.The distal section displayed evidence of thermal detachment with a v-grip controller.The implant coil was not returned for evaluation.The monofilament inside of the pusher section displayed a tail shape, which is produced by excessive handling force.Two fluoroscopic images provided by the customer were reviewed by a product safety physician, who found both images to be consistent with the complaint.Based upon the investigation analysis and available information, the reported complaint is confirmed; the implant coil was detached by handling force during the retraction process.However, it cannot be determined when and where the reported damage occurred.The heater coil was activated using a detachment controller, but the monofilament did not have any activation mark on it.The root cause cannot be determined without the missing components (implant coil, introducer).

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10429313
• Report Number: 2032493-2020-00212
• Device Sequence Number: 2898831
• Product Code: KRD
• UDI-Device Identifier: 00816777023513
• UDI-Public: (01)00816777023513(11)200309(17)250228(10)2003095PF
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 100408HFRM-V-A2
• Device Catalogue Number: 100408HFRM-V
• Device Lot Number: 2003095PF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 65