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

Model Number	100715HFRM-V
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
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 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 an embolization coil had difficulty detaching within the aneurysm.Additionally, the coil could not be advanced or retracted.The coil was ultimately detached within the aneurysm.The pusher broke upon removal.No intervention or patient injury was reported.The patient was reported to be doing "well.".
Additional Manufacturer Narrative
Investigation into the returned product found only the pusher and microcatheter to be present.The implant was not returned as it was implanted in the patient.The pusher was found to be stuck, protruding from both the proximal and distal end of the microcatheter.The pusher was found to be broken at the pusher transition location.The proximal end of the pusher was returned fully separated from the distal end.The distal end of the pusher was found to be stretched and broken proximal to the heater coil.The distal lead wire solder joints were broken.The heater coil was found to have indications of thermal detachment.The microcatheter was found to be smashed approximately two inches from the distal end.The monofilament did not appear to be have a full mushroom profile and the end condition did exhibit some signs of shearing damage.Based on the monofilament's end condition, the implant appears to have been broken off by a shearing force rather than by thermal detachment.The microcatheter was found to be smashed, which would contribute to the stuck pusher, but it cannot be confirmed when the damage to the microcatheter occurred.Due to the severe damage to the pusher and its electrical circuitry, the root cause of the non-detachment is unable to be determined.

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9330435
• Report Number: 2032493-2019-00268
• Device Sequence Number: 19295193
• Product Code: HCG
• UDI-Device Identifier: 00816777023568
• UDI-Public: (01)00816777023568(11)190301(17)240229(10)1903015WF
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: 02/29/2024
• Device Model Number: 100715HFRM-V
• Device Catalogue Number: 100722CSSR-V
• Device Lot Number: 1903015WF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR