MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME FRAMING COIL; EMBOLIZATION COIL

Model Number	181243HFRM-V-A
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2016
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 device was discarded at the user facility; therefore, an evaluation cannot be performed.
Event or Problem Description
It was reported that coil embolization treatment was being performed on a splenic artery aneurysm.After the coil was placed in the aneurysm, it would not detach.The v-grip controller was exchanged, but the coil still would not detach.An attempt was made to remove the entire coil; however, it was locked in position in the aneurysm.The delivery wire was torqued at the proximal end and, believing the coil had detached, the delivery wire was withdrawn; however, the distal part of the delivery wire stretched and then broke.A few centimeters of the hydroframe plus a few centimeters of the distal delivery wire coil remained in the splenic artery.No additional intervention was performed and there were no clinical consequences to the patient.The current patient status is reported to be fine.

• Brand Name: HYDROFRAME FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6268846
• Report Number: 2032493-2017-00024
• Device Sequence Number: 18854285
• Product Code: HCG
• UDI-Device Identifier: 00811425029770
• UDI-Public: (01)00811425029770(11)150929(17)200929(10)150929V6
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2016

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: 09/29/2020
• Device Model Number: 181243HFRM-V-A
• Device Lot Number: 150929V6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2016
• Initial Report FDA Received Date: 01/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1