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

Model Number	7110-0408-A2
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889)
Date of Event	01/10/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The coil was implanted and the remainder of 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 hemorrhage and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that an embolization coil was advanced into the aneurysm, tested, and detached.When the pusher wire was retracted, the distal end remained inside of the microcatheter.The microcatheter was retracted while pulling the distal end away from the aneurysm and a portion of the coil into the parent artery.The pusher wire fragment fell out of the microcatheter, and was successfully retrieved with a snare device.The coil was retracted into the microcatheter by means of inflating a balloon at the tip, and removing the balloon along with the microcatheter.A hemorrhage was noted on an angiogram.A balloon was inflated to stop the hemorrhage prior to the placement and removal of a ventriculostomy drain.Protamine was administered, and a nicardipine infusion was started.The patient died the day after the procedure.The cause of the death is unknown.
Additional Manufacturer Narrative
The associated product was not returned for evaluation; however, case images were provided and analyzed.The provided fluoroscopic images were reviewed and show the aneurysm being accessed.Subsequent images show the presence of extravascular contrast seen outside the parent artery consistent with the hemorrhage of either the parent vessel or aneurysm, which is consistent with the reported complaint.The mechanism nor specific location of the hemorrhage could not be definitively concluded with the given information.It could not be confirmed from the given images if the pusher broke as described in the complaint.Based on the investigation, findings, and the available information, the reported complaint could not be verified.As a result, the root cause of the failure or the product's involvement in the adverse event could not be determined.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7259809
• Report Number: 2032493-2018-00025
• Device Sequence Number: 834792
• Product Code: HCG
• UDI-Device Identifier: 00816777023667
• UDI-Public: (01)00816777023667(11)171010(17)220930(10)17101052B
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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?: No
• Operator of Device: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: 7110-0408-A2
• Device Lot Number: 17101052B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 04/19/2018
• 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: Death
• Patient Age: 65 YR
• Patient Weight: 74