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

Model Number	8410-0203
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult To Position (1467); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
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 investigation is currently underway.
Event or Problem Description
It was reported that while treating a 4mm ica terminus aneurysm, an lvis jr was deployed from mca to ica.A hypersoft 3d 3.5x8 was deployed and detached, then another hypersoft 3d 2.5x6 was deployed and detached.The third hypersoft 3d coil overshot the landing zone by 1cm.Suggestion was made to pull the coil back and if resistance was encountered it was suggested to stop.Resistance was encountered and he stopped.It was then suggested to detach the coil and he did.When he removed the coil, we noticed the distal coil of the pusher had stretched but the coil was deployed safely.We then switched to an sl10 because it is softer.A 2x3 hypersoft 3d was then used, the coil was not sitting in the aneurysm, it kept popping out into a1.The coil was pulled back gently to be repositioned and when we went to push the coil we realized it had spontaneously detached.The coil was still in the aneurysm and catheter tip was out of the aneurysm.The physician pushed a 2x4 stryker 360 standard and when he felt resistance in the catheter he stopped and pulled the catheter out effectively dragging out the detached hypersoft 3d which was half in the aneurysm and half in the microcatheter.No reported injury.Patient is said to be doing "fine".No reported injury.
Additional Manufacturer Narrative
The device was returned for analysis.The coil was not attached to the delivery pusher.The proximal side of the pusher was noted to be kinked.The device passed the electrical continuity test.The monofilament showed evidence of stretching.The pusher coil was noted to be intact.Based on the investigation and provided information, the complaint can be confirmed.The specific root cause of this complaint is unknown; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6248511
• Report Number: 2032493-2017-00011
• Device Sequence Number: 13642181
• Product Code: HCG
• UDI-Device Identifier: 00811425028094
• UDI-Public: (01)00811425028094(11)161103(17)211031(10)161103V5
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071939
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/30/2021
• Device Model Number: 8410-0203
• Device Catalogue Number: 8410-0408
• Device Lot Number: 161103V5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1