MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number	7110-0102
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.Two coils were implanted in the aneurysm.It is unknown which coil was associated with the loop that extended into the parent vessel; therefore, medwatch reports will be submitted for both coils.The second coil is captured in mfr report# 2032493-2018-00184.
Event or Problem Description
It was reported that a balloon-assisted coiling procedure was performed on a patient with a recurrent basilar tip saccular aneurysm.After delivery of a balloon catheter into the posterior cerebral artery, two coils were successfully placed in the aneurysm.Subsequently, a coil loop was noted to project at the basilar bifurcation, more towards the origin of the right p1 artery.The balloon was inflated multiple times, which repositioned the coil mass and centralized the coil loop at the basilar bifurcation.Both posterior cerebral arteries were patent.The decision was made to stop treatment at that point and maintain the patient on dual antiplatelet therapy for 3 months.The patient awoke from general anesthesia neurologically intact and was reported to be stable with no new neurological deficits upon hospital discharge.The patient is enrolled in a post-market clinical trial and is being monitored.
Additional Manufacturer Narrative
Additional information was received from the clinical research coordinator at the clinical trial site.The patient returned for a scheduled follow-up visit, per clinical trial protocol.There have been no adverse events, no abnormal sensory or motor deficits since the procedure, and the patient had no evidence of ischemic changes on imaging.The patient is taking aspirin, and has been advised to discontinue the plavix; the aspirin use will also be discontinued.Currently, the patient is noted to be doing well.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7871435
• Report Number: 2032493-2018-00185
• Device Sequence Number: 13931058
• Product Code: HCG
• UDI-Device Identifier: 00816777025319
• UDI-Public: (01)00816777025319(11)171213(17)221130(10)1712135YC
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091641
• 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): 08/17/2018

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: Other
• Device Expiration Date: 11/30/2022
• Device Model Number: 7110-0102
• Device Lot Number: 1712135YC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/28/2018
• 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: Required Intervention
• Patient Age: 37 YR