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

Model Number 100408HFRM-V

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned to the manufacturer.The investigation is underway.

Event Description

It was reported that during the treatment of an anterior communicating aneurysm, the coil was advanced out approximately 2cm.During removal, resistance was encountered, and the coil detached in the aneurysm.The coil was successfully removed with a snare device.Several attempts were made to clarify if the coil was thermally detached or detached; however, no further clarifying information has been provided.There was no reported patient injury.The patient was reported to be fine.

Manufacturer Narrative

The device was received with the dispenser hoop, introducer sheath, delivery pusher, and the implant, which was detached from the delivery pusher.The heater coil of the pusher did not have any burn damage, but did display compression damage.The rest of the pusher did not display any other notable damage.The implant had multiple kinks.The attachment monofilament displayed a tail shape.The root cause of the implant detaching is most likely due to the monofilament experiencing a force over the maximum specification, as indicated by the physical characteristics of the monofilament tip.

• Brand Name: HYDROFRAME FRAMING COIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8593169
• MDR Text Key: 144538422
• Report Number: 2032493-2019-00132
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636026985
• UDI-Public: (01)00812636026985(11)180829(17)230731(10)1808295UF
• Combination Product (y/n): N
• PMA/PMN Number: K090357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 100408HFRM-V
• Device Lot Number: 1808295UF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 05/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 24