MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number MV-00410HFLA

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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.The device was returned to the manufacturer for analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.

Event Description

It was reported that during treatment of an aneurysm, an embolization coil implant would not detach while positioned in the aneurysm.During an attempt to retract the coil, friction was encountered and the coil implant detached.The coil was entirely within the treatment site and was left in position.There was no reported patient injury or intervention.

Manufacturer Narrative

A search for non-conformance 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.The device was returned to the manufacturer for analysis.The investigation is currently underway.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.

Manufacturer Narrative

(h10) remove text from h10 of follow-up 1 (h10) replace with: the non-detachment of the implant was followed by an unexpected detachment upon retraction.The monofilament of the implant detached at the attachment bond area of the pusher, which was a result of the retraction forces.This is seen in the void in the attachment area where the monofilament should be fixed.The physical evaluation of the device could not identify the conditions or circumstances that led to the damages, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: HYDROFILL 10 ADVANCED
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11611970
• MDR Text Key: 243787140
• Report Number: 2032493-2021-00120
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987350987693
• UDI-Public: (01)04987350987693(11)190717(17)240630(10)1907171Y5
• Combination Product (y/n): N
• PMA/PMN Number: K113457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-00410HFLA
• Device Lot Number: 1907171Y5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1