MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23 (HDE); LVIS JR.

Model Number	172020-LVISJ-C-HDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Death (1802)
Date of Event	06/07/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Based on the information provided, the complaint cannot be confirmed.The device could not be evaluated as it remains within the patient.No device malfunction was reported with the mvi, inc.Devices used, however an adverse event occured following the procedure.(b)(4).
Event or Problem Description
The patient was reported to be a (b)(6) female presenting with antra communicating arteries, 7x5xx4mm aneurysm.The patient was electively admitted for treatment of the wide neck aneurysm.The patient was prepped, bilateral groins were prepped in usual fashion.Access was made using ultrasound guidance.Previously selected coiling views were selected.An attempt to cross the ipsilateral a2 segment with a balloon catheter and microcatheter was unsuccessful.Access the contralateral a2 and deployed a lvis stent.A microcatheter was advanced into the aneurysm and the microwire was removed.Angiographic runs were used to verify the position of the system.An attempted was made to re-access the aneurysm from the right a2 segment, but the microwire punctured the aneurysmal dome leading to excellent position.Act was normalized with protamine.Blood pressure was controlled to less than 140.After repeated attempts, access was made to the aneurysm from the right a2, a coil was deployed.Access was difficult through stent tynes so the access was changed to the left internal carotid artery.The anterior lobe of the aneurysm was coiled.Follow-up views revealed no active extravasation, but the physiologic monitoring remain diarrhea.Cerebral inflow plane slow.Access devices were removed and puncture site was covered.The patient was transported to the recovery area in stable condition.No immediate complications were encountered.Imaging revealed the lvis stent in good position.Additional information received 6/7/2016: the patient has been declared brain dead.The family is in the process of withdrawing support.Additional information received 6/10/2016: life support was withdrawn.Date of death is, (b)(6) 2016; 15:05.Additional devices used: micropuncture set, 0.035" j guide wire, 5fr pinnacle sheath, 0.035" terumo guide wire, simmons 2 catheter, cook shuttle sheath, 072 navien, echelon 10 microcatheter, headway 17 microcatheter, synchro 2 010 microwire, synchro 2 014 microwire, stryker target, penumbra smartcoil.

• Brand Name: LVIS JR 2.5X23 (HDE)
• Common Device Name: LVIS JR.
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5756905
• Report Number: 2032493-2016-00150
• Device Sequence Number: 10767705
• Product Code: NJE
• UDI-Device Identifier: 00812636020143
• UDI-Public: (01)00812636020143(11)160309(17)190309(10)16030935
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: H130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 03/09/2016
• Device Model Number: 172020-LVISJ-C-HDE
• Device Lot Number: 16030935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2016
• Initial Report FDA Received Date: 06/28/2016
• 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; Other
• Patient Age: 74 YR
• Patient Weight: 84