MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICAL HYPERSOFT; ARTIFICIAL EMBOLIZATION DEVICE

Model Number 100206HS-V-N

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/29/2019

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 discarded at the user facility; therefore, the alleged device issue could not be confirmed.

Event Description

It was reported that during use of an embolization coil for treatment of a basilar tip aneurysm, the proximal zebra marker located outside the patient on the pusher wire was thought to be in a different position on the pusher wire than expected.The coil was successfully placed and detached in the aneurysm.There was no reported patient injury and the patient is currently reported to be doing well.The issue was reported to the manufacturer one year after the event and the device was not returned for evaluation.No information was provided about adjunctive devices (e.G., catheter) which may have affected the relative position of the proximal marker.

• Brand Name: MICROPLEX HYPERSOFT HELICAL HYPERSOFT
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 10715790
• MDR Text Key: 212480322
• Report Number: 2032493-2020-00296
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170019463
• UDI-Public: (01)00810170019463(11)190111(17)231231(10)1901115NH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050954
• 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
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Model Number: 100206HS-V-N
• Device Catalogue Number: 100204HFIL-V
• Device Lot Number: 1901115NH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2019
• 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: 61 YR