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

Model Number	8410-0310-A2
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.Evaluation of the device revealed stretching of the proximal end of the implant, but the detachment zone was intact.The unit was sent for sem analysis that confirmed that the wire had a torsional break.The implant is stretched due to application of force that exceeded the tensile strength of the coils.The reported complaint details indicated the coil was being advanced at the time of the detachment; however, it is unknown how the coil was being manipulated.Based on the available information, the reported complaint is confirmed; however, the root cause cannot be determined.
Event or Problem Description
It was reported that while advancing a coil during a stent-assisted embolization treatment, the coil "felt odd." upon inspection under fluoroscopy, the coil had unexpectedly detached in the microcatheter.No portion of the coil had exited the microcatheter.A guide wire was used to successfully deploy the coil.There was no reported intervention or patient injury.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6645909
• Report Number: 2032493-2017-00148
• Device Sequence Number: 1049653
• Product Code: HCG
• UDI-Device Identifier: 00816777025166
• UDI-Public: (01)00816777025166(11)170106(17)211231(10)170106W5
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161452
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2017

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: 12/31/2021
• Device Model Number: 8410-0310-A2
• Device Lot Number: 170106W5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1