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

Model Number MV-00412HTDA

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

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

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.A search for non-conformances 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.

Event Description

It was reported, after detachment cycle had done, the implant could be confirmed to be detached under fluoroscopy, and the pusher was removed from the patient.However, upon visual inspection of the pusher outside the patient¿s body, the pusher was observed to be stretched.Considering the risk that pusher coil had been severed and left in the patient¿s body, the physician attempted to removed possible fragments of the pusher coil with a snare, but was unable to capture anything.No fragments were observed in the catheter either.Therefore, the procedure was completed.It was reported there was no patient health damage.

Manufacturer Narrative

The investigation of the returned coil system found the pusher bodycoil stretched and broken at the distal section, which is consistent with the alleged product issue.The pusher's monofilament showed a mushroom profile shape, this indicates that the implant was successfully detached from thermal activation using a detachment controller.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched pusher coil, but the stretched condition is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The visual analysis of the returned items found that the pusher bodycoil was stretched and broken at the distal section.Further inspection of the pusher found the monofilament with a mushroom profile, which indicates the implant experienced a thermal detachment.The marker band was not present on the pusher as the pusher bodycoil was broken at the distal section, and the distal portion of the pusher and the implant were not returned for evaluation.

Event Description

It was reported, after detachment cycle had done, the implant could be confirmed to be detached under fluoroscopy, and the pusher was removed from the patient.However, upon visual inspection of the pusher outside the patient¿s body, the pusher was observed to be stretched.Considering the risk that pusher coil had been severed and left in the patient¿s body, the physician attempted to removed possible fragments of the pusher coil with a snare, but was unable to capture anything.No fragments were observed in the catheter either.Therefore, the procedure was completed.It was reported there was no patient health damage.

• Brand Name: HYPERSOFT 3D-AV
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656
• MDR Report Key: 18449671
• MDR Text Key: 332166981
• Report Number: 2032493-2024-00029
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-00412HTDA
• Device Lot Number: 0000325369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• 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): Other