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

Model Number	181243HFRM-V
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
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 analysis.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It was reported that during embolization of an aneurysm, the implant coil did not detach.When the device was withdrawn, the implant coil detached.The delivery pusher appeared damaged.The implant was left in the aneurysm.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
The device was returned with the pusher.The implant, dispenser hoop and introducer were not returned.During physical inspection of the unit, multiple points of damage were found on the pusher.The pusher was severely stretched from the platinum coil toward the distal area of the pusher.Within this stretched portion of the pusher, the lead wires were found to be damaged and the monofilament was found to be severely tangled and damaged.The gold connector was found intact and the heater coil was found without burn marks.A thorough non-detachment analysis could not be performed due to the implant missing and due to the damaged lead wires.The root cause of the reported complaint cannot be definitively determined, but the observed damage is historically related to units that have been subjected to excessive tensile forces.

• 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: 9118587
• Report Number: 2032493-2019-00230
• Device Sequence Number: 1972184
• Product Code: HCG
• UDI-Device Identifier: 00816777023834
• UDI-Public: (01)00816777023834(11)180921(17)230831(10)1809215P7
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 08/31/2023
• Device Model Number: 181243HFRM-V
• Device Catalogue Number: 181243HFRM-V
• Device Lot Number: 1809215P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1