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

Model Number	8410-0102
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Hemorrhage, Subarachnoid (1893)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
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 hemorrhage as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during a coil embolization procedure, an aneurysm rupture occurred while using a non-microvention coil.The coil was left in place to tamponade the bleed.An attempt was then made to place the hydrosoft 3d coil; however, the coil stretched during positioning in the aneurysm.During an attempt to retrieve the coil, it pulled out the first coil that had been implanted, causing the bleeding to start again and worsen.The coils were removed along with the microcatheter, which allowed the patient to bleed into the subarachnoid space for 2-3 minutes.The procedure was completed with another company's products.The patient is reported to be in a medically induced coma, and was in critical condition.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7443494
• Report Number: 2032493-2018-00074
• Device Sequence Number: 19226293
• Product Code: HCG
• UDI-Device Identifier: 00811425027929
• UDI-Public: (01)00811425027929(11)160825(17)210731(10)160825V5
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K131948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: 07/31/2021
• Device Model Number: 8410-0102
• Device Catalogue Number: 8410-0102
• Device Lot Number: 160825V5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/19/2018
• 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: 76 YR