MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100408HS3D-V-A2

Device Problems Difficult or Delayed Positioning (1157); Separation Failure (2547); Detachment of Device or Device Component (2907)

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

Event Date 03/08/2021

Event Type  Injury  

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 by the physician and not returned to the manufacturer for evaluation.An image document provided by the physician contains a fluoroscopic image that shows a partially coiled aneurysm.Additionally, the image shows what appears to be coil elongated and stretched out of the aneurysm, extending to the distal section of the parent artery.This fluoroscopic image and the photo image of a broken coil segment contained in the snared used to retrieve the elongated coil confirms the complaint.Without the return and evaluation of the physical device, the investigation is unable to determine if a condition existed with the device that would have caused or contributed to the reported complaint.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 during treatment of an aneurysm of the internal carotid artery, an embolization coil implant would not detach after multiple repositioning attempts.Upon retraction, the implant became stretched and broke.The broken pieces of the coil were retrieved using a clot retrieval device.There was no reported patient injury.

• Brand Name: HYPERSOFT 3D-AV
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 11646019
• MDR Text Key: 249239037
• Report Number: 2032493-2021-00127
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777021120
• UDI-Public: (01)00816777021120(11)200310(17)250228(10)2003105WT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K131948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100408HS3D-V-A2
• Device Lot Number: 2003105WT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 57