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

Model Number	8510-0256-A2
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
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 returned to the manufacturer for evaluation.The invesitgation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that an embolization coil implant stretched and broke after deployment.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The device was received with the pusher coils stretched and broken with the distal section of the pusher not being returned.There was no damaged to the returned introducer.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched and damaged pusher, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: HYPERSOFT ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11457946
• Report Number: 2032493-2021-00065
• Device Sequence Number: 4041421
• Product Code: KRD
• UDI-Device Identifier: 00816777020888
• UDI-Public: (01)00816777020888(11)200114(17)241231(10)2001141WH
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 12/31/2024
• Device Model Number: 8510-0256-A2
• Device Lot Number: 2001141WH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1