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

Model Number	7110-0415-A2
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11478453
• Report Number: 2032493-2021-00073
• Device Sequence Number: 14400571
• Product Code: KRD
• UDI-Device Identifier: 00816777025258
• UDI-Public: (01)00816777025258(11)200930(17)250831(10)2009305WF
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 7110-0415-A2
• Device Lot Number: 2009305WF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/14/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1