MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 18 FRAMING COIL VTA; EMBOLIZATION COIL

Model Number	181139HFRM-V
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	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.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 discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.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 several coils were successfully implanted in an aneurysm after a non mv stent was deployed.Another coil was deployed partially in the catheter and partially in the aneurysm when the physician decided to re-position the catheter, causing the coil to stretch.During removal, the coil detached from the pusher wire.An attempt was made to retrieve the coil with a snare device; however, was unsuccessful.The coil was successfully removed with a stent retriever.There was no reported patient injury.The patient was reported to be doing okay.

• Brand Name: HYDROFRAME 18 FRAMING COIL VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8593172
• Report Number: 2032493-2019-00134
• Device Sequence Number: 2340046
• Product Code: HCG
• UDI-Device Identifier: 00816777023827
• UDI-Public: (01)00816777023827(11)181109(17)231031(10)1811095P7
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100454
• 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): 04/15/2019

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: 10/31/2023
• Device Model Number: 181139HFRM-V
• Device Catalogue Number: 181139HFRM-V
• Device Lot Number: 1811095P7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/08/2019
• 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
• Patient Age: 74 YR