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

Model Number	8510-0202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Cerebral (1889)
Date of Event	04/27/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.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.The device was used during the same procedure as was reported in mfr.Report# 2032493-2017-00125, 2032493-2017-00126, 2032493-2017-00128, 2032493-2017-00129, 2032493-2017-00130, and 2032493-2017-00131.
Event or Problem Description
It was reported that stent-assisted coil embolization was performed on an unruptured acom aneurysm.The patient was anticoagulated prior to the procedure with aspirin, plavix, and heparin.The lvis jr.Stent was successfully deployed without difficulty across the neck and seven (7) coils were placed in the aneurysm.After the final coil was placed, contrast extravasation from the dome of the aneurysm was noted.The hemorrhage stopped temporarily, but when the microcatheter was withdrawn, the bleeding continued.Protamine was administered.Balloon inflations were performed in the bilateral acas and the bleeding stopped; however, upon deflation of the balloons, the extravasation continued.Ultimately, the patient's intracranial pressure rose and her condition deteriorated.Two days after the procedure, the patient died.The surgeon stated that the stent did not cause the aneurysm rupture, and also stated that "the cause of the rupture was coil protrusion through the dome of the aneurysm.The patient was on aspirin, plavix, and heparin.Despite attempts to arrest flow with 2 balloons, the bleeding did not stop.".

• Brand Name: HYPERSOFT ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6609888
• Report Number: 2032493-2017-00127
• Device Sequence Number: 13698031
• Product Code: HCG
• UDI-Device Identifier: 00811425027738
• UDI-Public: (01)00811425027738(11)151006(17)201006(10)151006VC2
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2017

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: 10/06/2020
• Device Model Number: 8510-0202
• Device Lot Number: 151006VC2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 06/02/2017
• 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: 51 YR
• Patient Weight: 74