MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT; "NEUROVASCULAR EMBOLIZATION DEVICE / VASCULAR EMBOLIZATION DEVICE"

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown as the device was not identified.Therefore, a review of manufacturing documents could not be performed.The device was implanted in the patient and is not available for return to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that an embolization hyrdocoil was used in a study patient through an endovascular procedure and a small amount of filling defect was noted at the origin of the right pcomm artery.Repeat angiography following treatment demonstrated significant improvement in filling defect.The medications verapamil, eptifibatide, and aspirin were all administered to the patient.The outcome was resolved without sequelae.

• Brand Name: HYDROSOFT
• Type of Device: "NEUROVASCULAR EMBOLIZATION DEVICE / VASCULAR EMBOLIZATION DEVICE"
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise dr.; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12131372
• MDR Text Key: 260469688
• Report Number: 2032493-2021-00274
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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