MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 ADVANCED; VASCULAR EMBOLIZATION DEVICE

Model Number	7110-0405-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 returned to the manufacturer for analysis.The investigation is ongoing.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 the physician was performing a balloon assisted coiling procedure on the left middle cerebral artery (mca) at the bifurcation.While advancing the coil up the microcatheter and first segment of coil was in the aneurysm, the coil unexpectedly detached in the microcatheter without activating the detachment controller.A snare was used and successfully retrieved the coil.There was no report of injury to the patient, who was fine.
Additional Manufacturer Narrative
The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The investigation of the returned coil system found the implant severely stretched/damaged and to be thermally detached using a detachment controller.The monofilament profiles a mushroom shape at the tip indicating a successful detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the damaged implant, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11942558
• Report Number: 2032493-2021-00217
• Device Sequence Number: 19922709
• Product Code: KRD
• UDI-Device Identifier: 00816777023650
• UDI-Public: (01)00816777023650(11)191220(17)241130(10)1912201WF
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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: 11/30/2024
• Device Model Number: 7110-0405-A2
• Device Lot Number: 1912201WF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: 71 YR
• Patient Weight: 68