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

Model Number 100408HFRM-V

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467)

Patient Problems Death (1802); Thrombus (2101); Rupture (2208)

Event Date 02/02/2018

Event Type  Death  

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 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.

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
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 7376187
• MDR Text Key: 103651319
• Report Number: 2032493-2018-00055
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023513
• UDI-Public: (01)00816777023513(11)170921(17)220831(10)1709211WJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2022
• Device Model Number: 100408HFRM-V
• Device Lot Number: 1709211WJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death