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

Model Number	100408HFRM-V
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Difficult To Position (1467)
Health Effect - Clinical Codes	Death (1802); Thrombus (2101); Rupture (2208)
Date of Event	02/02/2018
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 and the remainder of the device were discarded at the user facility; therefore, a product analysis could not be performed.The instructions for use (ifu) identifies aneurysm rupture, coil migration or misplacement, clot formation, and death as potential complications associated with use of the device.
Event or Problem Description
It was reported that during the treatment of an acute anterior communicating artery aneurysm, the framing coil did not fully advance into the aneurysm, leaving approximately 1cm of the coil in the a1 segment.Coil loops had perforated the aneurysm; therefore, an attempt was made to detach the coil.The coil did not detach after four (4) attempts were made.A balloon was inflated to protect the aneurysm.After an attempt to resheath and remove the coil, the coil appeared to migrate into the middle cerebral m1 - m3 arterial segments.Additional coils were then implanted in the aneurysm.Part of the 1st coil was removed from the middle cerebral artery.A clot was then noted in the middle cerebral artery, and a stent retriever was used.The patient was reported to have died; however, it is unknown when the death occurred.The cause of the patient's death is also unknown.
Additional Manufacturer Narrative
Additional information was received on march 28, 2018 from the distributor: date of death - (b)(6) 2018.During treatment of a ruptured acute anterior communicating artery aneurysm, the physician tried to re-sheath and remove the coil; however, the coil detached partially inside the aneurysm and the microcatheter.The aneurysm was coiled, then part of the 1st coil was removed from the middle cerebral using an endovascular snare.The clot was apparent in the middle cerebral artery, m2-m3 and a stent retriever was utilized.The physician describes the coil as broken; however, the coil may have stretched.The patient is reported to be deceased 3 days following the procedure on (b)(6) 2018.The cause of death is ischemic / thromboembolic- mca.

• 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: 7376187
• Report Number: 2032493-2018-00055
• Device Sequence Number: 2023595
• Product Code: HCG
• UDI-Device Identifier: 00816777023513
• UDI-Public: (01)00816777023513(11)170921(17)220831(10)1709211WJ
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2018

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: Physician
• Device Expiration Date: 08/31/2022
• Device Model Number: 100408HFRM-V
• Device Lot Number: 1709211WJ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2018
• Supplement Date Received by Manufacturer: 02/25/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/26/2018
• 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