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

Model Number 100619HFRM-V-A1-CN

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2017

Event Type  malfunction  

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.The device has not yet been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that an embolization coil unexpectedly detached in the aneurysm without use of the controller.Both segments of the coil were removed from the patient.There was no reported intervention or patient injury.The patient's status is reported to be fine.

Manufacturer Narrative

The pusher was returned for analysis.Investigation analysis revealed the resistance of the system to be within specification, and passed the 4 way (angular) v-grip continuity test.The strain relief was noted to be folded and shrunk.The attachment tether had a stretched tail and a rebound length of 0.059", indicating the device experienced forces that exceeded its specification.The implant coil was not returned for evaluation, and there are no signs of damage on the pusher.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: HYDROFRAME FRAMING COIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 6875987
• MDR Text Key: 86612585
• Report Number: 2032493-2017-00236
• Device Sequence Number: 1
• Product Code: HGC
• UDI-Device Identifier: 00812636027043
• UDI-Public: (01)00812636027043(11)170303(17)220228(10)170303F9
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

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
• Device Operator: Physician
• Device Expiration Date: 02/28/2022
• Device Model Number: 100619HFRM-V-A1-CN
• Device Lot Number: 170303F9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 08/23/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 52