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

Model Number	8410-0304-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during embolization of the coil, it would not detach despite multiple attempts.Physician then pulled the coil back into the catheter, while doing this the coil finally detached and went out into the vessel.The coil stretched and was left in the patient.Additional information received stated that there was no issue with the catheter.There was no reported injury to the patient.
Additional Manufacturer Narrative
A user medwatch was received (b)(4) on (b)(6) 2022, notifying and providing awareness of a medical device report as received by the fda.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 investigation is ongoing.The instructions for use (ifu) identifies premature or difficult or delayed coil detachment as a potential complication associated with use of the device.
Additional Manufacturer Narrative
The investigation of the returned coil system found the proximal connector kinked, the hypotube bent, and the pusher broken at the transition area.The implant and the part of the pusher distal to the broken area was not returned for evaluation.Due to the severe damage to the pusher, the investigation could not determine if the attachment monofilament experienced a tensile break or a thermal detachment; furthermore, the pusher was unable to be tested to determine if conditions existed that would have cause or contributed to the reported non-detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15383350
• Report Number: 2032493-2022-00353
• Device Sequence Number: 5820739
• Product Code: KRD
• UDI-Device Identifier: 00816777021250
• UDI-Public: (01)00816777021250(11)220406(17)270331(10)0000177915
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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 Model Number: 8410-0304-A2
• Device Lot Number: 0000177915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown