MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICALVTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100306HS-V-A2

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 evaluation.The investigation is currently ongoing.

Event Description

It was reported that an embolization coil implant kept coming out of the aneurysm neck during placement.The coil was removed from the patient where it was observed that the coil was the incorrect size.There was no reported patient injury or intervention.

Manufacturer Narrative

Summary of device evaluation: the investigation of the returned coil found the implant damaged at proximal.And measured to be the correct (hypersoft helical 100306hs-v) implant coil size, that matches the returned pouch label and complaint file.The implant loops and coil length were measured in spec.No damage was found on the returned pusher and introducer sheath.The damage found on the implant can result in a distorted implant shape (i.E.Larger loop diameter).The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.The investigation of the returned device did not any other anomaly that would have caused or contributed to the reported complaint.

• Brand Name: MICROPLEX HYPERSOFT HELICALVTA
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 12340476
• MDR Text Key: 267243660
• Report Number: 2032493-2021-00334
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777024114
• UDI-Public: (01)00816777024114(11)200601(17)250531(10)2006015PH
• Combination Product (y/n): N
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100306HS-V-A2
• Device Lot Number: 2006015PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 89