MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 ADVANCED; VASCULAR EMBOLIZATION DEVICE

Model Number 7110-0415-A2

Device Problems Stretched (1601); Difficult or Delayed Separation (4044)

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

Event Date 02/10/2021

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 implanted in the patient and not returned to the manufacturer for analysis.The alleged product issue could not be confirmed.

Event Description

It was reported that during treatment of a ruptured aneurysm, an embolization coil implant did not detach.It then stretched, and a portion of the stretched coil remains implanted in the patient.It was the physician's opinion that the stretched segment would not be "a major contributing issue for the outcome of the patient." there was no reported patient injury or intervention.The patient's current status is unknown.

Manufacturer Narrative

Additional information received stated that the implant coil stretched down to the arm and that the ruptured aneurysm being treated was considered high grade and acute.

• Brand Name: HYDROFRAME 10 ADVANCED
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11478453
• MDR Text Key: 239801202
• Report Number: 2032493-2021-00073
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00816777025258
• UDI-Public: (01)00816777025258(11)200930(17)250831(10)2009305WF
• Combination Product (y/n): N
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7110-0415-A2
• Device Lot Number: 2009305WF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1