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

Model Number	101036HFRM-V-A2
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
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 use of the device.
Event or Problem Description
It was reported that coil embolization was performed as treatment for a right internal carotid pcom artery aneurysm.An attempt was made to reposition the coil and during retraction, the coil stretched and then unexpectedly detached.The distal end of the implant coil remained in the aneurysm and approximately 90% of the implant coil was outside the aneurysm.Attempts were made to retrieve the detached coil with a snare device, but they were unsuccessful.The implant coil was stretched and thinned in its proximal segment as a result of the coil retrieval attempts.The stretched segment of coil outside the aneurysm was pressed against the wall of the internal and primitive straight carotid arteries, the brachiocephalic trunk, and the aorta down to the common femoral artery.The patient was placed on heparin post-operatively.There was no reported patient injury and there were no clinical complications for the patient.

• 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: 10429336
• Report Number: 2032493-2020-00213
• Device Sequence Number: 2898832
• Product Code: KRD
• UDI-Device Identifier: 00816777023612
• UDI-Public: (01)00816777023612(11)190117(17)231231(10)1901175WF
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 101036HFRM-V-A2
• Device Catalogue Number: 101036HFRM-V
• Device Lot Number: 1901175WF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/20/2020
• 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